The document discusses the FDA's Inactive Ingredient Guide (IIG), which lists inactive ingredients that are present in approved drug products. It provides information on obtaining the IIG and describes the contents and purpose of the guide. The IIG is intended to help identify inactive ingredients that may require less extensive review if they are already present in approved drug products for a particular route of administration. It lists ingredients alphabetically and provides information like routes of administration, CAS numbers, number of NDAs, and potency ranges.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
Medical Spa (MedSpa) directors and workers should be aware of the FDA laws and policies that govern their industry, including those of their primary vendors. This rule may serve to warn directors and clinicians in this and other medical practices the risks of working with those compound pharmacies that do not comply.
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
The document discusses medical device labeling requirements in Russia. It outlines several key Russian laws and regulations pertaining to medical device registration, customs clearance, advertising, sales, distribution, and use. It emphasizes that labeling must be in Russian and match the information in the registration certificate. It recommends using over-labeling with essential information in Russian as the most common way for foreign manufacturers to comply with labeling language requirements. Failure to properly translate labeling could result in seized products or additional taxes and fees.
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
This document summarizes a presentation given by Michael Swit on the 510(k) process for medical device clearance. The presentation covers the legal framework for 510(k) submissions, considerations for choosing device claims and introducing new features, evaluating device modifications that require new 510(k) filings, and the 510(k) review process. It provides guidance on strategies for obtaining 510(k) clearance, including starting with a narrow intended use and adding features incrementally, and the types of device changes that typically trigger a new 510(k).
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
Medical Spa (MedSpa) directors and workers should be aware of the FDA laws and policies that govern their industry, including those of their primary vendors. This rule may serve to warn directors and clinicians in this and other medical practices the risks of working with those compound pharmacies that do not comply.
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
The document discusses medical device labeling requirements in Russia. It outlines several key Russian laws and regulations pertaining to medical device registration, customs clearance, advertising, sales, distribution, and use. It emphasizes that labeling must be in Russian and match the information in the registration certificate. It recommends using over-labeling with essential information in Russian as the most common way for foreign manufacturers to comply with labeling language requirements. Failure to properly translate labeling could result in seized products or additional taxes and fees.
Pharmaceutical industries invest billions of dollars, Euros in these highly risky health care solutions, for this Intellectual property protection is essential. Innovator company enjoys a period of "data exclusivity" during which their pre-clinical and clinical trials data may not be referenced in the regulatory filings of another company for the same drug substance.
This document discusses various regulatory requirements for medical devices including CE marking in the European Union, ISO 13485 certification, US FDA 510(k) clearance, establishment registration and listing with the US FDA, and quality system regulation 21 CFR 820. I3 Consulting offers services to help clients achieve compliance with these requirements, such as technical consultancy, documentation preparation, gap analyses, product testing, notified body audits, training, and implementation support.
Hatch- waxman act (The drug price competition and patent term restoration act...Mohit Kumar
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
Three New draft guidances related to compounding of human drugsDr. Reena Malik
FDA has issued three new draft guidance documents related to compounding of human drugs:
1) Addressing prescription requirements for compounded drugs under Section 503A.
2) Defining outsourcing facilities under Section 503B as facilities that compound sterile drugs and have elected to register with FDA.
3) Explaining that hospitals can compound drugs under Section 503A based on individual prescriptions or for limited quantities in advance, but FDA will not take action if certain conditions are met for distribution within affiliated facilities within a 1 mile radius.
Taiwan medical device registration and approval chart - EMERGOEMERGO
Taiwan regulates medical devices through the Pharmaceutical Affairs Act and Regulations for Governing the Management of Medical Devices. The process involves classifying the device, appointing a Taiwan agent, preparing quality system documentation for submission, and obtaining approval. Device classification and complexity of approval requirements vary, with Class I generally having the simplest process taking 1-2 months, Class II taking 10-12 months, and Class III taking 10-12 months and requiring a committee review.
The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.
Medical device approval chart for Russia - EMERGOEMERGO
The regulatory process for medical devices in Russia involves classifying the device, appointing an authorized representative, submitting a registration dossier including technical documentation and clinical data to Roszdravnadzor (RZN), addressing any requests for additional information, and ultimately receiving a registration certificate to market the device in Russia. The process can take 6-12 months depending on the device class.
New EPA Rule to prevent untreated frack wastewater from being processed by mu...Marcellus Drilling News
A new rule (i.e. law) by the federal Environmental Protection Agency that will prevent untreated frack wastewater from being processed by local sewage treatment plants. The new rule is called "Effluent Limitations Guidelines and Standards for the Oil and Gas Extraction Point Source Category." The rule is set to go into effect within the next few weeks.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
When do drug patents expire and when can generic drugs launch?thinkBiotech
From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the patent provisions of the 1984 Hatch-Waxman Act
The Russian Ministry of Industry and Trade reconsidered restrictions on the supply of medical devices for state procurement in July 2014. The restrictions affect state and municipal procurements of medical devices from a closed list. If at least two bids with local products from Russia, Belarus or Kazakhstan are submitted for tender, buyers will be unable to procure medical devices originating from other countries. The local products must be confirmed by a certificate of origin issued by a local authorized agency. Certain categories of medical devices are subject to the restrictions, including syringes, osteosynthesis implants, ECG devices, and surgical instruments.
The document discusses requirements for facilities involved in manufacturing generic drugs to self-identify with the FDA. It states that under the Generic Drug User Fee Amendments of 2012, facilities must electronically self-identify annually. This information is used to determine facilities required to pay user fees and promote supply chain transparency. The document provides details on the types of facilities that must self-identify, including those manufacturing active pharmaceutical ingredients or finished dosage forms. It also outlines the information required in self-identifications, such as D-U-N-S numbers and Facility Establishment Identifiers.
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...Michael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
Andy Schmeltz, Global President of Pfizer Oncology, presented at the Cowen and Company Health Care Conference on March 14, 2018. The presentation discussed Pfizer's growing oncology portfolio, fueled by drugs like IBRANCE and XTANDI, with potential for multiple new drug approvals and indications in the coming years. It noted forward-looking statements are subject to risks and uncertainties. The presentation also provided an overview of Pfizer's rich oncology pipeline including drugs and indications in various stages of clinical trials and registration. A key focus is advancing access to treatments through outcomes data and real-world evidence generation to redefine life with cancer.
ZMPCML041000.13.01 FDA Approved (registration information)Painezee Specialist
This document provides information on the establishment registration and device listing for Ventlab Corp., including their registered establishment number, the owner and operator, and that they operate as a contract manufacturer. It lists a lumbar orthosis device as an example with its proprietary name, classification, product code, and regulation number. The page also contains links to additional FDA databases and information.
Gui final referencing_approved _oct 2020Ajay B. Kumar
This document provides guidance for industry on referencing approved drug products in ANDA submissions. It clarifies the definitions and appropriate uses of key terms like listed drug, reference listed drug (RLD), and reference standard. The RLD is the specific drug product on which an ANDA applicant relies, and it is usually a drug approved under section 505(c) of the FD&C Act. The reference standard is the product used for bioequivalence testing, and it is usually but not always the same as the RLD. Applicants must identify the RLD in their basis of submission and may request a change to the RLD. The guidance aims to resolve confusion around these terms.
Premarket Notification 510(k) for Biologics [Autosaved].pptxSusmithaTella2
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
This document discusses various regulatory requirements for medical devices including CE marking in the European Union, ISO 13485 certification, US FDA 510(k) clearance, establishment registration and listing with the US FDA, and quality system regulation 21 CFR 820. I3 Consulting offers services to help clients achieve compliance with these requirements, such as technical consultancy, documentation preparation, gap analyses, product testing, notified body audits, training, and implementation support.
Hatch- waxman act (The drug price competition and patent term restoration act...Mohit Kumar
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
Three New draft guidances related to compounding of human drugsDr. Reena Malik
FDA has issued three new draft guidance documents related to compounding of human drugs:
1) Addressing prescription requirements for compounded drugs under Section 503A.
2) Defining outsourcing facilities under Section 503B as facilities that compound sterile drugs and have elected to register with FDA.
3) Explaining that hospitals can compound drugs under Section 503A based on individual prescriptions or for limited quantities in advance, but FDA will not take action if certain conditions are met for distribution within affiliated facilities within a 1 mile radius.
Taiwan medical device registration and approval chart - EMERGOEMERGO
Taiwan regulates medical devices through the Pharmaceutical Affairs Act and Regulations for Governing the Management of Medical Devices. The process involves classifying the device, appointing a Taiwan agent, preparing quality system documentation for submission, and obtaining approval. Device classification and complexity of approval requirements vary, with Class I generally having the simplest process taking 1-2 months, Class II taking 10-12 months, and Class III taking 10-12 months and requiring a committee review.
The document provides an overview of the Waxman-Hatch Act of 1984, which established the modern generic drug approval pathway in the United States. It discusses the reasons for its creation, key provisions such as bioequivalence standards and patent certification requirements, and subsequent amendments. The Act sought to balance increased availability of low-cost generic drugs with incentives for continued pharmaceutical innovation.
Medical device approval chart for Russia - EMERGOEMERGO
The regulatory process for medical devices in Russia involves classifying the device, appointing an authorized representative, submitting a registration dossier including technical documentation and clinical data to Roszdravnadzor (RZN), addressing any requests for additional information, and ultimately receiving a registration certificate to market the device in Russia. The process can take 6-12 months depending on the device class.
New EPA Rule to prevent untreated frack wastewater from being processed by mu...Marcellus Drilling News
A new rule (i.e. law) by the federal Environmental Protection Agency that will prevent untreated frack wastewater from being processed by local sewage treatment plants. The new rule is called "Effluent Limitations Guidelines and Standards for the Oil and Gas Extraction Point Source Category." The rule is set to go into effect within the next few weeks.
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
Lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
When do drug patents expire and when can generic drugs launch?thinkBiotech
From DrugPatentWatch.com - When do drug patents expire, and when can generic drugs launch? An overview of patents, non-patent regulatory exclusivities, and specific US and EU factors influencing generic drug launch.
This document summarizes the Hatch-Waxman Act, which established the modern system for regulating generic drugs in the US. The Act aims to make generic drugs more accessible by streamlining the approval process for generics while also providing incentives to brand name drug companies. It allows generics to challenge drug patents and grants exclusivity periods to first generic applicants and brand name drugs for new chemical entities. The Orange Book lists approved drug products and related patent information.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the patent provisions of the 1984 Hatch-Waxman Act
The Russian Ministry of Industry and Trade reconsidered restrictions on the supply of medical devices for state procurement in July 2014. The restrictions affect state and municipal procurements of medical devices from a closed list. If at least two bids with local products from Russia, Belarus or Kazakhstan are submitted for tender, buyers will be unable to procure medical devices originating from other countries. The local products must be confirmed by a certificate of origin issued by a local authorized agency. Certain categories of medical devices are subject to the restrictions, including syringes, osteosynthesis implants, ECG devices, and surgical instruments.
The document discusses requirements for facilities involved in manufacturing generic drugs to self-identify with the FDA. It states that under the Generic Drug User Fee Amendments of 2012, facilities must electronically self-identify annually. This information is used to determine facilities required to pay user fees and promote supply chain transparency. The document provides details on the types of facilities that must self-identify, including those manufacturing active pharmaceutical ingredients or finished dosage forms. It also outlines the information required in self-identifications, such as D-U-N-S numbers and Facility Establishment Identifiers.
The Drug Price Competition and Patent Term Restoration Act of 1984: The Basi...Michael Swit
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, September 2009 at Teva Parenterals, with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
Andy Schmeltz, Global President of Pfizer Oncology, presented at the Cowen and Company Health Care Conference on March 14, 2018. The presentation discussed Pfizer's growing oncology portfolio, fueled by drugs like IBRANCE and XTANDI, with potential for multiple new drug approvals and indications in the coming years. It noted forward-looking statements are subject to risks and uncertainties. The presentation also provided an overview of Pfizer's rich oncology pipeline including drugs and indications in various stages of clinical trials and registration. A key focus is advancing access to treatments through outcomes data and real-world evidence generation to redefine life with cancer.
ZMPCML041000.13.01 FDA Approved (registration information)Painezee Specialist
This document provides information on the establishment registration and device listing for Ventlab Corp., including their registered establishment number, the owner and operator, and that they operate as a contract manufacturer. It lists a lumbar orthosis device as an example with its proprietary name, classification, product code, and regulation number. The page also contains links to additional FDA databases and information.
Gui final referencing_approved _oct 2020Ajay B. Kumar
This document provides guidance for industry on referencing approved drug products in ANDA submissions. It clarifies the definitions and appropriate uses of key terms like listed drug, reference listed drug (RLD), and reference standard. The RLD is the specific drug product on which an ANDA applicant relies, and it is usually a drug approved under section 505(c) of the FD&C Act. The reference standard is the product used for bioequivalence testing, and it is usually but not always the same as the RLD. Applicants must identify the RLD in their basis of submission and may request a change to the RLD. The guidance aims to resolve confusion around these terms.
Premarket Notification 510(k) for Biologics [Autosaved].pptxSusmithaTella2
The document summarizes the key aspects of the 510(k) premarket notification process for biologics. It explains that 510(k) is required to market a new device and demonstrates substantial equivalence to a legally marketed predicate device. The submission must include device descriptions, intended use, and clinical/nonclinical test results. There are three types of 510(k) submissions. The process involves FDA review within 90 days to determine substantial equivalence or request additional information. If cleared, the product can be marketed immediately.
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a firm can submit: Traditional, special, and abbreviated. Each 510(k) is a premarket notification, which if cleared, grants the firm permission by the FDA to market the device; but each one has different benefits and processes that medical device firms can take advantage of...
This document outlines the FDA's refuse to accept (RTA) policy for 510(k) submissions. It aims to clarify the necessary elements and contents of a complete 510(k) submission to allow the FDA to conduct a substantive review. The acceptance review determines if a submission is administratively complete based on objective criteria in acceptance checklists. If not complete, the FDA will inform the submitter within 15 days and identify any missing elements. The goal is to focus review resources on complete submissions and improve overall review time.
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Essential Regulatory Documents in Clinical TrialsAnand Butani
Maintaining and storing the essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s.
In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
The document provides information on how a product is developed, including literature searches, sources for information on innovators and patents, and criteria for procuring active pharmaceutical ingredients (APIs). It discusses preformulation studies including stress testing APIs under various conditions like heat, humidity, acids, bases and metals. The document also covers topics like therapeutic equivalence codes, national drug codes, drug master files, exclusivity, and types of patents listed in the Orange Book.
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Why Compliance is a Tough Pill to Swallow – NutraceuticalsAffiliate Summit
This presentation is from Affiliate Summit West 2014 (January 12-14, 2014 in Las Vegas, NV). Session description: Discussion of strategies for manufacturers and marketers of nutraceuticals to avoid both FTC and FDA scrutiny, as well as recent FDA warning letters and trending enforcement tactics.
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
Dr. D'vorah Graeser presented on freedom to operate considerations for biosimilars. She has a PhD in pharmacology and experience in intellectual property. Her presentation discussed how submarine patents, process patents, the FDA approval process, and trade secrets can impact a biosimilar applicant's ability to freely operate. In particular, she noted the uncertainty around the effect of process patents and trade secret protection. In conclusion, she emphasized the need to be aware of potential patent issues and stated that the current FDA process for biosimilars remains unsettled.
Dr. D'vorah Graeser presented on freedom to operate considerations for biosimilars. She has a PhD in pharmacology and experience in intellectual property. Her presentation discussed how submarine patents, process patents, the FDA approval process, and trade secrets can impact a biosimilar applicant's ability to freely operate. In particular, she noted the uncertainty around the effect of process patents and trade secret protection. In conclusion, she emphasized the need to be aware of potential patent issues and stated that the current FDA process for biosimilars remains unsettled.
AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Su...Jon Lendrum
The document provides an overview of a workshop on assembling 510(k) submissions for the FDA. It discusses selecting a predicate device, organizing data, and preparing the actual 510(k) submission. Key points include understanding FDA Form 3654 (Standards Data Report), tips and best practices for 510(k) submissions, potential pitfalls, and common mistakes. The workshop objectives are to help attendees understand how to select a predicate device, collect and organize required data, and understand the overall 510(k) process.
The document discusses the FDA 510(k) premarket notification process for medical devices. It explains that Class I, II, and III medical devices intended for commercial distribution in the US require FDA clearance obtained through a 510(k) or Premarket Approval (PMA). A 510(k) involves demonstrating that a new device is substantially equivalent to a predicate device already legally marketed in the US. The submission must provide device descriptions, intended use, performance testing results and labeling to establish safety and effectiveness.
Các trường hợp cấu thành việc trì hoãn, từ chối, hạn chế hoặc từ chối kiểm tra thuốc hoặc thiết bị. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU
Handling of a fda inspection [compatibility mode]Kiran Kota
The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.
A) Study in detail about Para - IV filing. B) Case studies for Para - IV Filing.Aakashdeep Raval
This document discusses paragraph IV (P-IV) filings under the Hatch-Waxman Act. It provides details on:
1) P-IV filings allow generic drug companies to file an Abbreviated New Drug Application (ANDA) to challenge a patent before it expires.
2) If the original drug company sues for patent infringement within 45 days, approval is automatically stayed for 30 months.
3) The first generic company to file a successful P-IV challenge receives 180 days of market exclusivity prior to other generics entering.
Patent Due Diligence in the Sale-Acquisition of a Medical Device Company, by ...SHIMOKAJI IP
One of the most important assets of a medical device company is often its patent portfolio. The portfolio can include issued patents, patent applications, and patentable inventions that are not the subject of issued patents or pending patent applications. Whether the seller or buyer of a medical device company, it is imperative to know what assets are in the company’s patent portfolio and factors that affect their value.
Commercially available, off the shelf patent databases do not often exist to hold the company’s patent portfolio information – at least for many medical device companies of a small to moderate size. Instead, the patent information might be in an excel spreadsheet kept by someone internally in the company. The information might be in the form of paper files kept in a file cabinet.
So, where do you look for patent information?
This document provides an overview of common instrumental analytical techniques used in chromatography and spectroscopy. It describes various chromatographic techniques including thin layer chromatography, column chromatography, gas chromatography, and high performance liquid chromatography. It also outlines several spectroscopic techniques such as atomic absorption spectroscopy, colorimetry, and UV-visible spectroscopy. The document explains the basic principles, components, and applications of these analytical methods for separating and analyzing mixtures.
The document discusses Investigational New Drug Applications (INDs), which are required for clinical trials of new drugs. It outlines the key components of an IND, including an introductory statement, investigator's brochure, protocols, chemistry/manufacturing information, and previous human experience. It also describes IND amendments, annual reports, and the roles of the sponsor and investigator. The overall purpose of an IND is to provide information to the FDA on a new drug's safety before it can be tested in humans.
Fractional factorial designs (FFDs) are used to efficiently study many factors using fewer experimental runs than a full factorial design. FFDs exploit redundancy in estimating interactions to select a subset of runs. Regular FFDs have desirable properties like balance and orthogonality. Resolution indicates how interactions are aliased, with higher resolutions preferred. FFDs are useful in screening experiments to identify important factors efficiently before further optimization. Software helps select appropriate FFDs based on desired resolution and aliasing.
This document discusses herbal medicines and their use in the pharmaceutical industry. It provides information on patient use of herbal remedies, why herbal products are in demand, approaches to developing herbal formulations, standardizing herbs, guidelines for using herbs safely, and interacting with other medications. The document addresses issues like herbal products not being well-tested, lacking quality control, and having imprecise potency, while also noting two sides to herbs in terms of benefits and risks.
Herbal medicine involves the use of whole plants to promote health and treat disease, drawing on a tradition of human use for over 60,000 years. It views disease more broadly by addressing underlying causes and individual expression rather than just symptoms. Herbal medicines are prescribed to restore homeostasis and promote optimal cellular nutrition and elimination. Around 1 in 5 people in the UK regularly use herbal medicine, and it is regulated through organizations like the National Institute of Medical Herbalists. Herbal medicines are prescribed individually based on a comprehensive medical history and clinical examination.
The document discusses Investigational New Drug Applications (INDs), which are required for clinical testing of new drugs. It describes the key components of an IND including an introductory statement, investigator's brochure, protocols, chemistry and manufacturing information, and annual reports. It also defines important terms like sponsor and investigator and outlines the regulatory requirements for INDs.
This document provides an introduction to water systems for pharmaceutical use. It discusses the importance of water quality for pharmaceutical processes and products. It outlines various water types like purified water, highly purified water, and water for injections. It emphasizes that water systems must be properly designed, installed, operated and maintained according to GMP to ensure consistent production of water meeting quality specifications. It also discusses common water contaminants and the need to monitor water sources and treat water appropriately based on its chemistry and contaminants.
Good Manufacturing Practices (GMPs) establish minimum standards for methods, facilities, and controls used in manufacturing drugs to ensure they are safe, have the appropriate identity and strength, and meet quality and purity standards. GMP violations can result in severe consequences for drug manufacturers such as product seizures, recalls, shutdown of facilities, and large financial penalties. Current trends in GMPs include a risk-based approach, international harmonization of quality standards, and proposed amendments regarding validation and cross-contamination prevention.
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
The document discusses Drug Master Files (DMFs), which provide confidential detailed information to the FDA in support of applications. It defines 5 types of DMFs and outlines their typical contents. These include manufacturing processes and facilities, active pharmaceutical ingredients, packaging materials, excipients, and reference information. The summary provides guidelines on submitting DMFs, required content for each type, quality controls, stability testing, and the FDA review process. Holders must adhere to good manufacturing practices and be willing to allow inspections.
This document outlines the history of drug development and approval processes in the United States from 1820 to 1997. It describes key milestones and legislation that established regulations for new drug applications (NDAs). NDAs were first required in 1938 to show drug safety, and in 1962 were amended to require proof of efficacy. The FDA now reviews NDAs to ensure the benefits of new drugs outweigh the risks based on clinical trial data.
The EMEA (European Medicines Agency) is a decentralized body of the European Union headquartered in London. It was established in 1995 and coordinates the evaluation and supervision of medicines for human and veterinary use throughout the EU. It is composed of various committees including the CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use) which are responsible for assessment and authorization of medicines. The EMEA ensures that medicines are evaluated based on quality, safety and efficacy with the goal of protecting public health.
This document discusses key considerations for dosage form design and formulation. It explains that pharmaceutical formulation involves selecting excipients to solubilize, thicken, stabilize, flavor, and otherwise modify drug substances for patient delivery. Proper dosage form design requires considering the physical and chemical properties of drug substances and ensuring compatibility with excipients. Preformulation studies characterize the drug's properties including solubility, dissolution rate, and stability. Understanding these properties helps determine the appropriate dosage form and formulation to provide stable, effective delivery of the active drug to patients.
This document defines various microbiology terms related to sterilization and disinfection. It discusses sterilization techniques like heat, filtration, and radiation. It also covers chemical disinfectants including phenols, bisphenols, biguanides, halogens, and chlorine. Physical methods like heat, filtration, refrigeration, and radiation can kill microbes. Chemical disinfectants have varying mechanisms of action, with phenols and halogens damaging cell membranes and bisphenols inhibiting fatty acid synthesis. Proper evaluation of disinfectant efficacy involves tests against standard microbes.
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
This document discusses designing around patents from the perspectives of both patent holders and competitors. It notes that patent holders seek broad patent protection to maximize monopoly profits and minimize successful design around efforts, while competitors aim to create non-infringing alternative products without bearing the monopoly costs of the patent. The document outlines strategies for patent holders to draft claims to make designing around more difficult and for competitors to develop design around approaches in light of legal precedents like Festo v. Shoketsu, which impacted the doctrine of equivalents.
Clinical trials are conducted in phases to evaluate the safety and efficacy of new drugs. Phase 1 trials involve 10-20 healthy volunteers to determine toxicity and pharmacokinetics. Phase 2 trials involve 100-200 patients to identify effective doses and further evaluate safety. Phase 3 trials involve up to 1000 volunteers to study less common side effects, compare to standard treatments, and evaluate long-term safety and effectiveness. Phase 4 trials monitor drugs after approval in 5000-10,000 patients to identify rare or long-term issues.
Clinical trials progress through phases (preclinical, I-IV) to evaluate treatments safely in humans. Preclinical testing occurs in labs and animals. Phase I studies evaluate safety in 20-80 healthy volunteers. Phase II expands to 100-300 patient volunteers to assess efficacy. Phase III further tests efficacy in 1,000-3,000 patients. FDA approval requires compliance with Good Clinical Practice guidelines to protect subject rights and ensure credible data. Key elements include oversight by independent review boards, informed consent, qualified investigators and sponsors, adherence to protocols, and comprehensive record keeping.
Clinical research in India is growing rapidly due to several factors:
- India has a large population with a growing disease burden similar to developed countries. This provides opportunities for clinical trial recruitment.
- Regulatory reforms have made the approval process for clinical trials much faster, within 6-8 weeks for some applications.
- Costs for conducting clinical trials are around half of Western countries, providing significant cost savings for sponsors.
- There is an increasing pool of experienced investigators and staff familiar with Good Clinical Practice who can conduct trials to international standards.
- The pharmaceutical industry and contract research organizations see India as an important location for outsourcing various stages of drug development to take advantage of the opportunities.
The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription and over-the-counter drugs. CDER oversees new drug development and approval, drug safety, and drug advertising and promotion. It reviews New Drug Applications, monitors drug safety after approval, develops regulations and guidance, and communicates with industry and the public about drugs and drug development.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
In this slide, we'll explore how to set up warehouses and locations in Odoo 17 Inventory. This will help us manage our stock effectively, track inventory levels, and streamline warehouse operations.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
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ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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2. FREEDOM OF INFORMATION
(FOI)
• Contains categories of frequently
requested FDA documents.
• Check for availability on FDA web site.
• Can also check specific FOI sites
which have been established by the
following agency offices :
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3. Center for drug evaluation and research
(CDER)
Center for biologics evaluation and research
(CBER)
Center for devices and radiological health
(CDRH)
Center for veterinary medicine (CVM)
Dockets management branch (DBM)
Office of regulatory affairs
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4. Advisory committee transcripts
Application integrity policy test
Clinical investigators inspection list
Information on commissioning
Compliance policy guides
Compliance program guidance manual
Directory of public affair specialist
Directory of state officials
Enforcement reports
Guides to inspection
Import alerts
Import refusal reports
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5. Inspectors technical guide
Lab information bulletins
Laboratory procedures manual
Medical devices reports
NADA FOI summaries
Notice of opportunity for hearing
Products approval
Regulatory procedures manual
Warning letters
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6. A handbook for requesting information
and records from FDA
The guidance given in this
handbook is intended to facilitate
requests for both public information
and records.
This handbook has been updated
in response to the Electronic
Freedom of Information Act
Amendments of 1996.
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7. Obtaining Public Information
Certain documents that are prepared for
public distribution--such as press releases,
consumer publications, speeches, and
congressional testimony--are available from
FDA without having to file a Freedom of
Information Act (FOIA) request. Many of
these documents are available on FDA's
Internet site (http://www.fda.gov/default.htm).
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8. Obtaining Information Through FOIA
→ FOIA allows anyone to request copies
of records
→ FOIA pertains to existing records only
→ Does not require agencies to create
new records to comply with a request
→ FOIA requests must be specific enough
to permit an FDA employee who is familiar
with the subject matter to locate records
in a reasonable period of time.
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9. Under FOIA, certain records may be withheld in
whole or in part from the requestor if they fall
within one of nine FOIA exemptions.
Exemption 2: Protects certain records
related solely to FDA's internal rules and
practices.
Exemption 3: Protects information that is
prohibited from disclosure by other laws.
Exemption 4: Protects trade secrets and
confidential commercial or financial
information.
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10. Exemption 5: Protects certain interagency
and intra-agency communications.
Exemption 6: Protects information about
individuals in personnel, medical, and similar
files when disclosure would constitute a
clearly unwarranted invasion of privacy.
Exemption 7: Protects records or information
compiled for law enforcement purposes when
disclosure (A) could reasonably be expected
to interfere with enforcement proceedings;
03/22/15 www.PharmInfopedia.com
11. (B) would deprive a person of a right to a fair trial
or an impartial adjudication;
(C) could reasonably be expected to constitute an
unwarranted invasion of personal privacy;
(D) could reasonably be expected to disclose the
identity of a confidential source;
(E) would disclose techniques and procedures for
law enforcement investigations or prosecutions, or
would disclose guidelines for law enforcement
investigations or prosecutions, if such disclosure
could reasonably be expected to risk
circumvention of the law.
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12. How To Make an FOIA Request
a.Requestor's name, address, and telephone
number.
b. A description of the records being sought. The
records should be identified as specifically as
possible. A request for specific records that are
releasable to the public can be processed much
more quickly than a request for "all information"
on a particular subject. Also fees for a more
specific and limited request will generally be
less.
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13. c. Separate requests should be
submitted for each firm or product
involved.
d. A statement concerning
willingness to pay fees, including
any limitations.
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14. Electronic Reading Rooms
The 1996 amendments to the Freedom
of Information Act (FOIA) mandate
publicly accessible "electronic reading
rooms" with agency FOIA response
materials and other information
routinely available to the public, with
electronic search and indexing features.
03/22/15 www.PharmInfopedia.com
15. Freedom of Information (FOI) Reference Sheet
This table descripts the types of information that are releasable through
the Freedom of Information (FOI) process from FDA
ELEMENTS PREMARKET APPROVAL
(PMA) Documents 21 CFR
814.9
INVESTIGATIONAL
DEVICE EVALUATION
(IDE) Documents 21 CFR
812.38
PREMARKET
NOTIFICATION (PMN/510k)
21 CFR 807.95
Appeals Only through FOI Staff, HFZ-82 Only through FOI Staff, HFZ-
82
Only through FOI Staff, HFZ-82
Adverse
Effects /
Reaction
Reports in
PMA's, IDE's &
510(K)'s
Released by ODE, to the patient
only, after receipt of written
request. If requested by an
attorney or family member; need
notarized authorization from the
patient.
Not releasable, except to
provide a patient with their
own report
Released by ODE, to the patient
only, after receipt of written
request. If requested by an
attorney or family member; need
notarized authorization from the
patient.
Approval
Letters
Letter available through Dockets
Management with the SS&E
package or on the Internet
Not Releasable Only releasable only by FOI Staff,
HFZ-82
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16. Approvable
Letters
Generally not releasable. See
FOI Staff.
N/A N/A
Bench/Clinical
Data
Not Releasable Not Releasable Not Releasable
Consent Forms Releasable only to those
participants in the PMA study if
reviewer is able to identify the
individual in the document. If
requested by an attorney or
family member, it must be
accompanied by a notarized
authorization from the patient.
Releasable only to those
participants in the IDE study if
reviewer is able to identify the
individual in the document. If
requested by an attorney or
family member, it must be
accompanied by a notarized
authorization from the patient.
Releasable only to those
participants in the 510k study & if
reviewer is able to identify the
individual in the document. If
requested by an attorney or family
member, it must be accompanied
by a notarized authorization from
the patient.
Certifications of
Documents
Only through FOI Staff, HFZ-82 Only through FOI Staff, HFZ-
82
Only through FOI Staff, HFZ-82
Denials Only through HFZ-82 and
coordinated through General
Counsel
Only through HFZ-82 and
coordinated through General
Counsel
Only through HFZ-82 and
coordinated through General
Counsel
Labeling Contained in summary of safety
and effectiveness (SS&E) and
released by Dockets
Management; some may be
found on the Internet
N/A or Not Releasable Releasable by FOI HFZ-82 after
PDN
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17. Manufacturer's
Standard
Operating
Procedures
(SOP), In-house
Quality
Assurance
Procedures
Not Releasable Not Releasable Not Releasable
Minor Deletions Only through HFZ-82 N/A Only through FOI Staff, HFZ-82
Not
Substantially
Equivalent
Document
N/A N/A May be releasable, see FOI Staff
Patient Records Releasable only to those
participants in the PMA study if
reviewer is able to identify the
individual in the document. If
requested by an attorney or
family member, it must be
accompanied by a notarized
authorization from the patient.
Not releasable except to
provide a patient with their
own report
Not releasable except to provide a
patient with their own report
PMA
Supplements
Review for proprietary
information prior to release
N/A N/A
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18. Recession
Letters
Releasable only after recession
is effective
May be releasable, see FOI
Staff
Releasable only after recession is
effective
Reviewer's
Notes
Review for proprietary
information prior to release
Not Releasable Review for proprietary
information prior to release
Substantially
Equivalent
Letter
N/A N/A Available on the Internet as of
7/97, otherwise only releasable
through FOI, HFZ-82
Summary of
Safety and
Effectiveness
(SSE)
Releasable through ODE or
Dockets Management (with a
Docket Number); approvals after
9/96 on Internet
N/A Available on the Internet for
510(K)'s found SE after March
1996. Voluntarily submitted by
manufacturer and intended for
public release. Note that the
SS&E were not required prior to
4-18-91.
Withdrawn
Submission
Not Releasable, see FOI Staff N/A Not Releasable - see FOI Staff
Withdrawn
Letter
Not Releasable - see FOI Staff Not Releasable - see FOI Staff Not Releasable - see FOI Staff
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19. Inactive Ingredient GuideInactive Ingredient Guide
• IIG is a part of FOI Special Topics, which
comes under Drug Information division of
CDER.
• IIG was prepare on January 1996
• PDF version available on FDA from March
2000 – scanned document
• Divided in 8 Parts – alphabetically.
• Total Pages 155
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20. Inactive Ingredient Guide
• IIG consist of all the inactive ingredient
present in approved drug product or
conditionally approved drug products
currently marketed for human use.
• IIG is compile by DDIR – Division of Drug
Information Resources.
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21. Purpose
• Once Inactive Ingredient appears in
currently approved drug products for
particular route of administration, the
Inactive Ingredient would not usually be
considered NEW and may require less
extensive review.
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22. Inactive Ingredient
• 21 CFR 210.3 (b) 8 defines Inactive
Ingredient as any component other than
Active Ingredient.
• Only those which are present in Final
dosage form.
• Not include any processing material used,
which removed afterwards and not present
in Final dosage form.
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23. Inactive Ingredient
• Inactive Ingredient, which is Physically or
Chemically combined with Active
ingredient to facilitate DRUG
TRANSPORT are considered as Inactive
Ingredient.
• Reactant in Radiopharmaceuticals.
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24. Contaminants
• IIG does not represents contaminant
found in approved drug products.
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25. Synonyms
• Since many Ingredient have Synonyms, if
one can not find any particular Ingredient,
he may contact Drug Information Officer,
who can assist with the help of Dictionary
maintained by DDIR.
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26. Proprietary Name
• DDIR does not always include Proprietary
names of Ingredient in IIG.
• In such situations, one has to search data
for such ingredient under individual
component entries.
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27. Toxics
• If any ingredient of IIG is found to be
Carcinogenic or Teratogenics or
Embryotoxic, please NOTIFY to DDIR
• DDIR draws attention of medical officers
and pharmacological reviewer towards
that specific Inactive Ingredient
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28. Color Additives
• Specially listed at last in Appendix
• Certification Branch of Division of Color
Technology had classified colors.
– Permanently listed color additives
– Provisionally listed color additives
– Delisted color additives
• Consult 21 CFR 74 and 82 for detail
information on color additives
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29. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
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30. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Alphabetically listed
Starting from ACACIA to ZINC SULFATE
Then few excipients as per Numerical starting
e.g. 1,1,1 - TRICHLOROETHANE
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31. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Route; Dosage form; specific
i.e.
Oral; Tablet; Delayed action, Enteric Coated
Alphabetical order : Buccal, I.M., I.V.,
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32. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Chemical Abstract Service No. - 9 digit
Helpful in Computer-assisted search with the
National Library of Medicine’s Online Databases
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33. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Total No. of NDA filed,
in which Inactive Ingredient currently appears
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34. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Date of obtaining Last NDA approval,
Helps to find Latest NDA
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35. IIG Description
NAME ROUTE /
DOSAGE
FORM
CAS
NO.
NDA
COUNT
LAST NDA
APPROVAL
DATE
POTENCY
RANGE
Minimum to Maximum Value of Excipient used
i.e. 0.5 mg – 5 mg
In many excipient Potency Range is given in
Percentage of final product
i.e. 0.5 % - 5 %
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36. Structures
• Chemical Structures of Inactive Ingredient
are not mentioned in IIG.
• If any one requires for review, it can be
obtained from DDIR Chemist.
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