March 12., 2013 presentation to the San Diego Chapter of the American Society for Quality, focusing on:
• The 2012 Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety & Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provisions
• Other Trends
FDA Update: The Impact of FDASIA and The ElectionsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN), focusing on:
• The 2012 Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety & Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provisions
• Other Trends
November 2012 presentation to the BIOCOM Reimbursement and Market Access series, focusing on:
• The 2012 Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety & Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provisions
• Other Trends
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Right-to-Try is legislation that allows terminally ill patients to access investigational treatments which have passed Phase I testing through the Food and Drug Administration (FDA), but are not available yet to the public because they have not yet been approved by the FDA. Int his webinar, Professor Bateman-House, Assistant Professor in the Division of Medical Ethics at New York University Langone Medical Center, discusses the legislation, breaks down the language, and explains how Right-to-Try can affect cancer patients.
Keynote presentation at the Skin Summit, sponsored by Pharmaceutical Education Associates, in February 2008, in Philadelphia. Talk focused on new drug regulatory issues, especially those arising under the 2007 Food and Drug Administration Amendments Act (FDAAA).
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
FDA Update: The Impact of FDASIA and The ElectionsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN), focusing on:
• The 2012 Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety & Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provisions
• Other Trends
November 2012 presentation to the BIOCOM Reimbursement and Market Access series, focusing on:
• The 2012 Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety & Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provisions
• Other Trends
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Right-to-Try is legislation that allows terminally ill patients to access investigational treatments which have passed Phase I testing through the Food and Drug Administration (FDA), but are not available yet to the public because they have not yet been approved by the FDA. Int his webinar, Professor Bateman-House, Assistant Professor in the Division of Medical Ethics at New York University Langone Medical Center, discusses the legislation, breaks down the language, and explains how Right-to-Try can affect cancer patients.
Keynote presentation at the Skin Summit, sponsored by Pharmaceutical Education Associates, in February 2008, in Philadelphia. Talk focused on new drug regulatory issues, especially those arising under the 2007 Food and Drug Administration Amendments Act (FDAAA).
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
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
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
Review of the de novo 510(k) Petition process that allows for the reclassification of innovative devices that are automatically placed into Class III by FDA.
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
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Drug Safety – An Overview of FDA Powers under FDAAAMichael Swit
Presentation to Conference on Marketing Applications jointly sponsored by San Diego Regulatory Affairs Network (SDRAN) and the Orange County Regulatory Affairs (OCRA) Discussion Group, in November 2009. Talk focused on the new powers granted FDA under the 2007 Food and Drug Administration Amendments Act (FDAAA).
George A. Burdock, Ph.D. of Burdock Group Consultations explains the regulatory approval process for animal feed and pet food ingredients, detailing the process of food additive petitions, GRAS reviews and notifications, and AFCOO definitions.
Scientific Evidence for Claims: The Importance of Presentation, Gap Analysis ...Burdock Group Consultants
Presented by Dr. Ray A. Matulka at IFT15 on July 14th at 1:30 PM.
The ability to “claim” that a food of food ingredient has a beneficial effect on the structure or function of the body or supplies an essential nutrient is a great asset for enhancing consumer awareness. There are several different types of claims that may be stated on food packaging, and each requires a different level of scientific substantiation to prove that the claim is truthful and not misleading. In addition, the wording of the claim is critical to both the consumer acceptance and regulatory compliance, both on the label and in associated physical and electronic media venues. The recent court cases concerning POM Wonderful and the indication by regulatory authorities that double-blind, placebo-controlled clinical trials are necessary for all claims indicates a significant shift in requirements for claim substantiation. Further, proposed changes to the nutrition facts label will have an impact on nutrient content claims. The speakers will discuss the current types of claims that can be stated on labeling and in the media, how to evaluate various data sets to determine if there is enough evidence to substantiate a claim, and how to align your product in the marketplace to get the greatest impact. Dr. Matulka presented the necessary steps to research, test and gather the scientific evidence that is needed to support several different types of claims, including health claims, structure/ function, and nutrition claims, and to prove that these claims are "truthful and not misleading." Dr. Matulka also discussed the importance of presentation and timing when deciding to pursue a claim.
Learning Objectives:
• How to evaluate various data sets to determine if there is enough evidence to substantiate a claim
• How to align your product in the marketplace to get the greatest impact
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Dietary Supplements, Combination Products, and Veterinary MedicineMichael Swit
Presentation to San DIego Regulatory Affairs Network (SDRAN) on key issues relating to regulation of dietary supplements, Combination Products, and Veterinary Medicine.
FDA Regulation of Combination ProductsMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
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
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
Review of the de novo 510(k) Petition process that allows for the reclassification of innovative devices that are automatically placed into Class III by FDA.
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
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Drug Safety – An Overview of FDA Powers under FDAAAMichael Swit
Presentation to Conference on Marketing Applications jointly sponsored by San Diego Regulatory Affairs Network (SDRAN) and the Orange County Regulatory Affairs (OCRA) Discussion Group, in November 2009. Talk focused on the new powers granted FDA under the 2007 Food and Drug Administration Amendments Act (FDAAA).
George A. Burdock, Ph.D. of Burdock Group Consultations explains the regulatory approval process for animal feed and pet food ingredients, detailing the process of food additive petitions, GRAS reviews and notifications, and AFCOO definitions.
Scientific Evidence for Claims: The Importance of Presentation, Gap Analysis ...Burdock Group Consultants
Presented by Dr. Ray A. Matulka at IFT15 on July 14th at 1:30 PM.
The ability to “claim” that a food of food ingredient has a beneficial effect on the structure or function of the body or supplies an essential nutrient is a great asset for enhancing consumer awareness. There are several different types of claims that may be stated on food packaging, and each requires a different level of scientific substantiation to prove that the claim is truthful and not misleading. In addition, the wording of the claim is critical to both the consumer acceptance and regulatory compliance, both on the label and in associated physical and electronic media venues. The recent court cases concerning POM Wonderful and the indication by regulatory authorities that double-blind, placebo-controlled clinical trials are necessary for all claims indicates a significant shift in requirements for claim substantiation. Further, proposed changes to the nutrition facts label will have an impact on nutrient content claims. The speakers will discuss the current types of claims that can be stated on labeling and in the media, how to evaluate various data sets to determine if there is enough evidence to substantiate a claim, and how to align your product in the marketplace to get the greatest impact. Dr. Matulka presented the necessary steps to research, test and gather the scientific evidence that is needed to support several different types of claims, including health claims, structure/ function, and nutrition claims, and to prove that these claims are "truthful and not misleading." Dr. Matulka also discussed the importance of presentation and timing when deciding to pursue a claim.
Learning Objectives:
• How to evaluate various data sets to determine if there is enough evidence to substantiate a claim
• How to align your product in the marketplace to get the greatest impact
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
Dietary Supplements, Combination Products, and Veterinary MedicineMichael Swit
Presentation to San DIego Regulatory Affairs Network (SDRAN) on key issues relating to regulation of dietary supplements, Combination Products, and Veterinary Medicine.
FDA Regulation of Combination ProductsMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
FDA Regulation of Combination ProductsMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
Dietary Supplements, Combination Products, and Veterinary MedicineMichael Swit
Presentation to San DIego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Test Review Course, on key issues relating to regulation of dietary supplements, Combination Products, and Veterinary Medicine.
Key Issues in FDA & FTC Regulation of Dietary SupplementsMichael Swit
Webinar presentation sponsored by Compliance2Go, focusing on:
♦ Basics
♦ New Dietary Ingredients
♦ Claims Allowed
♦ GMPs and Other Regulatory Requirements
♦ Adverse Events
♦ The FTC Perspective
Keynote presentation at the Ophthalmic Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in September 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under the 2007 Food and Drug Administration Amendments Act (FDAAA).
Keynote presentation at the Nasal Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in October 2007, in Philadelphia. Talk focused on new drug regulatory issues, especially those arising under the 2007 Food and Drug Administration Amendments Act (FDAAA).
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
February 21, 2013 presentation in webinar sponsored by Compliance2Go, with a focus on the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Webinar sponsored by Compliance2Go focusing on different ways that drug and medical device firms can secure approval of products outside of traditional approaches. Presentation covers:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
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
August 29, 2012 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course, with a focus on:
* new animal drug applications
* generic new animal drugs applications
* species and uses
Creative Strategies in Dealing with FDA for Approval of Drugs and Medical Dev...Michael Swit
Webinar sponsored by PSC Creative Learning, covering key ways that FDA allows drug and device companies to seek alternative ways to secure approval/clearance of drugs and medical devices. Presentation covers:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
FDAAA -- An Abbreviation in Search of MeaningMichael Swit
February 2008 presentation to the San Diego Regulatory Affairs Network (SDRAN) on the Impact of the Food & Drug Administration Amendments Act of 2007 on the Drug and Biologics Industries
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”Michael Swit
June 12, 2009 presentation to the Southern California Biomedical Council on FDA enforcement, with a focus on:
FDA Regulatory/Enforcement Authority --
Understanding
FDA Enforcement Trends
Drugs
Devices
Clinical Trials
Collateral Consequences of FDA Violations
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Presentation to San Diego Regulatory Affairs Network (SDRAN) February 12, 2015 meeting with a focus on the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
Similar to The Impact of FDASIA on the Drug and Device Industries (20)
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.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 23, 2018
Responsibilities of the office bearers while registering multi-state cooperat...Finlaw Consultancy Pvt Ltd
Introduction-
The process of register multi-state cooperative society in India is governed by the Multi-State Co-operative Societies Act, 2002. This process requires the office bearers to undertake several crucial responsibilities to ensure compliance with legal and regulatory frameworks. The key office bearers typically include the President, Secretary, and Treasurer, along with other elected members of the managing committee. Their responsibilities encompass administrative, legal, and financial duties essential for the successful registration and operation of the society.
How to Obtain Permanent Residency in the NetherlandsBridgeWest.eu
You can rely on our assistance if you are ready to apply for permanent residency. Find out more at: https://immigration-netherlands.com/obtain-a-permanent-residence-permit-in-the-netherlands/.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
Defending Weapons Offence Charges: Role of Mississauga Criminal Defence LawyersHarpreetSaini48
Discover how Mississauga criminal defence lawyers defend clients facing weapon offence charges with expert legal guidance and courtroom representation.
To know more visit: https://www.saini-law.com/
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
against which they can evaluate those classes of AI applications that are probably the most relevant for them.
2. www.duanemorris.com
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• This presentation, and the materials included
herewith, are provided for general educational
purposes and should not be construed as legal
advice.
2
3. www.duanemorris.com
What I Will Cover
• The Election and the Political Arena
• FDASIA – The Food & Drug Administration Safety
& Innovation Act of 2012
– User Fees (only briefly)
– Drug Provisions
– Device Provisions
– General Provision
• Other Trends
3
5. www.duanemorris.com
FDA -- Future under Obama II
• FDA – Commissioner Hamburg will remain
– Has shown indicia of understanding industry impacts
– But, will be under pressure due to New England Compounding
Center scandal to aggressively protect the public health
Enforcement – look for it to be even more aggressive
“Park Doctrine” – keep an eye out for more use
• Sequestration –
– lopped about $209,000,000 off FDA budget for rest of FY
2013 (which started on 10/1/2012)
– ± 1,000 FDA employees if bulk of cuts taken from staffing
– FDA is trying to avoid furloughs
– will impact user fee programs as well
5
7. www.duanemorris.com
Pediatric Drugs
• PREA (Pediatric Research Equity Act) and BPCA
(Best Pharmaceuticals for Children Act) – made
permanent (they were subject to sunset).
– still must have a written request to do pediatric studies to get
the 6-month exclusivity
– PREA studies are eligible to qualify for exclusivity if in a
written request
• Initial pediatric plan – FDASIA requires the
submission of the plan no later than 60 days after the
End of Phase 2 (EOP2) Meeting – outline of studies and
and any request for waiver or deferral
7
8. www.duanemorris.com
Rare Pediatric Drug Voucher Program
• “Priority Review Voucher” – for approval of a product
for a “rare pediatric disease” – i.e., one that is an orphan
that primarily affects children up to age 18 [§ 529(a)(3)]
• Get voucher that can be used for a later NDA to get
priority review (even if not entitled otherwise)
• Limits:
– drug must be a new chemical entity
– can’t seek approval in adults in the application
– must request designation as a rare pediatric disease at same time as
requesting orphan status or fast track designation
– have to market within 365 days of approval or voucher may be revoked
8
9. www.duanemorris.com
Accelerated Drug/Biologic Approval
• “Serious or life-threatening disease or condition”
• Fast track = accelerated situation with an unmet
need
• Based on:
– determination that the product has an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit, or
on a clinical endpoint that can be measured earlier than
irreversible morbidity or mortality, that is reasonably likely to
predict an effect on irreversible morbidity or mortality or other
clinical benefit, taking into account the severity, rarity, or
prevalence of the condition and the availability or lack of
alternative treatments.” § 506(c)(1)(A)
9
10. www.duanemorris.com
Accelerated Drug/Biologic Approval …
• Evidence to support that a drug has the effect
required (see prior slide) – may come from:
– epidemiological, pathophysiological, therapeutic,
pharmacologic, or other evidence developed using biomarkers,
for example, or other scientific methods or tools.”
§506(c)(1)(B)
• Still have to do post-approval studies –
– but, those studies no longer have to validate a surrogate
endpoint or confirm effect on the clinical endpoint
– rather, “verify and describe the predicted effect on the
irreversible morbidity or mortality or other clinical benefit”
10
11. www.duanemorris.com
Breakthrough Therapies
• FDA may accelerate approvals -- § 506(a)(1)
• Defined as a drug intended to treat, alone or in
combination:
– a serious or life-threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed early
in clinical development
• Designation – any time at or after submitting IND
– FDA – 60 days to decide if a breakthrough therapy
– If designated, FDA must act to “expedite development and review of the
application” via such measures as meetings and development advice
– Guidance – no later than January 2014
11
12. www.duanemorris.com
Other Drug Provisions
• Orphan Drugs
– Grants program –
extended through 2017
appropriates $30 million per year for grants
– Eliminated need for qualifying testing costs to occur after the product is
designated an orphan
• Risk-Benefit Decisions – amends § 505(d) to mandate
that FDA:
– “implement a structured risk-benefit assessment framework in the new drug
approval process to facilitate the balanced consideration of benefits and
risks, a consistent and systematic approach to the discussion and regulatory
decisionmaking, and the communication of the benefits and risks of new
drugs.”
12
13. www.duanemorris.com
Drug Supply Chain
• Unique Facility Identifier (UFI) – to be created along
with an electronic database
• Drugs (or devices) imported from unregistered
foreign facilities – deemed misbranded (means they can
be detained under § 801 of Act)
• Drug will be deemed adulterated -- if made, processed
or packed at a facility where owner/operator delayed,
denied, or limited an inspection or refused to permit
entry or inspection
• GMPs – law amended to make clear that oversight of
suppliers is a GMP duty for drug makers
13
14. www.duanemorris.com
Drug Supply Chain …
• Inspection schedule – is supposed to be risk-based;
focusing on several factors in § 510(h)(4)
• Foreign government inspections – FDASIA
authorizes FDA to make pacts to recognize foreign
inspections – in § 809(b)
• Demand for documents – in advance or in lieu of an
inspection, FDA may require a drug maker to provide
records to FDA – amends § 704(a)
• Extraterritorial jurisdiction – granted to FDA over any
violation of the Act for any article intended for import
into the U.S. -- § 311 – broad inspection power
14
15. www.duanemorris.com
Drug Supply Chain …
• Commercial drug importers – must register with FDA;
failure to do so will render the imported drug
misbranded
– “Good Importer Practices” to be established by regulation by
July 2015 by which importers must be able to ensure that
imported drugs comply with the Act and/or the Public Health
Service Act (PHSA) for biologics
• New “Admission Standards” – to be implemented by
regulation by FDA by January 9, 2014
– allows FDA to take a risk-based approach to vetting drug
imports
– importers can be required to submit info electronically
15
16. www.duanemorris.com
Drug Supply Chain …
• Increased penalties for knowing adulteration of a
drug that causes serious adverse health
consequences or death in humans or animals
– Prison – up to 20 years; and/or
– Fine -- $ 1 million
• Trafficking in counterfeit drugs – now a federal
criminal code violation – 18 USC § 2320(a)(4)
– Prison – up to 20 years; and/or
– Fine -- $ 5 million
16
17. www.duanemorris.com
Antibiotics – G.A.I.N.
• Generating Antibiotic Incentives Now (G.A.I.N.) –
new § 505E of the Act
– “Qualified Infectious Disease Product” (QIDP) – adds five
years to existing Waxman-Hatch exclusivity (including
extending, for NCE, period during which ANDA can’t be
filed, from 4 to 9 years)
– QIDP – “an antibacterial or antifungal drug for human use
intended to treat serious or life-threatening infections,
including those caused by …”
an antibacterial or antifungal resistant pathogen; or
certain “qualifying pathogens”
17
18. www.duanemorris.com
Antibiotics – G.A.I.N. …
• “Qualifying Pathogens” – to be included in a list to be
maintained by FDA – includes those pathogens that:
– have potential to pose a serious risk to public health (e.g.,
resistant gram positive; multi-drug resistant gram negative
bacteria; multi-drug resistant TB; and Clostridium difficile)
– list to be made not later than July 9, 2014
• QIDP Designation – may be requested any time before
submitting an NDA
– FDA must decide within 60 days
• Implementing regulations – due by July 9, 2014
• Priority Review – post-FDASIA QIDP NDAs – get
18
19. www.duanemorris.com
Medical Devices
• Investigational Device Exemptions (IDE) --
amended § 520(g) of the Federal Food, Drug, and
Cosmetic Act (“the Act”) to make clear that an IDE
study did not have to be likely to support a PMA or
510(k) –
– a draft FDA guidance had suggested this was needed
– allows for more developmental studies under IDE process
• Least Burdensome Standard – clarified what is
“necessary” in the way of clinical studies to be those that
are the “minimum required information” to support a
PMA or 510(k)
19
20. www.duanemorris.com
Medical Devices …
• Decision Making and Documentation – new § 517A
– FDA must document the scientific and regulatory rationale for
“significant decisions” (not defined) on IDEs, 510(k)’s, & PMAs
– Documentation
must note “significant controversies or differences of opinion” and
how resolved
applicants are to be given documentation upon request
– Appeals
have 30 days to appeal significant decisions
have right to a telephone or in-person meeting
FDA has 45 days to decide the appeal (30 days if a meeting held)
20
21. www.duanemorris.com
Medical Devices …
• Modifications to 510(k)’d Devices – adds § 510(n)(2)
– Withdraws the 2011 draft guidance on 510(k) changes
– Reverts back to the 1997 guidance
– 18 months for FDA to report to Congress on how to properly
handle changes to 510(k) clearances
– No new guidance allowed during the 12 months after report
goes to Congress
• Recalls – new § 518A
– FDA must create a program to assess information on device
recalls, removals and corrections
– Use info to identify strategies to mitigate risk from devices
21
22. www.duanemorris.com
Medical Devices …
• IDE Clinical Holds
– Amends § 520(g) to give FDA specific authority to issue a
clinical hold if FDA finds that a device presents an
unreasonable risk to subject’s safety or other reasons (to be
established by regulation)
– Determination of unreasonable risk must assess
qualifications of investigators
information about the device
study design
the condition for which the device is being studied; and
health status of subjects
– FDA must provide written decision within 30 days of request
by sponsor to lift hold22
23. www.duanemorris.com
Medical Devices …
• De Novo Petition Changes – changes to § 513(f)(2)
– eliminates need to submit a 510(k) first and have it declared
non-substantially equivalent (NSE)
can directly request
can include draft of special controls that would apply
– FDA has 120 days to decide
– FDA can decline if:
concludes device belongs in Class III;
that appropriate special controls are not possible; or
identifies an appropriate predicate
23
24. www.duanemorris.com
Medical Devices …
• Reclassification – amends § 513(e)(1)(A)(i) to allow for
reclassification petitions to be done by administrative
order, rather than regulation
– obviates need for formal notice and comment rulemaking
– can be initiated by FDA or upon petition
BUT
– still must:
be published in Federal Register
hold a classification panel meeting
consider comments in docket
24
25. www.duanemorris.com
Medical Devices …
• Third-party review and inspection programs –
reauthorized until 2017
• Humanitarian Device Exemption (HDE) – now can
make a limited profit. Previously, only pediatric devices
qualified -- §520(m)(6)(A)
• Unique Device Identifier (UDI) –
– required FDA to issue proposed rule by 12/31/2012; actually
proposed in July (77 Fed. Reg. 40735; July 10 , 2012)
– FDA has 6 months from close of comment period to finalize
rule – comment period expired November 7 – so final rule due
on May 7, 2013
25
26. www.duanemorris.com
Medical Devices …
• Postmarket Surveillance
– Authority to order now can be exercised at time of FDA
clearance or approval
device maker has 30 days to submit a plan after getting order
FDA has 60 days to review plan
36 months or longer (if FDA and maker agree)
Surveillance must start within 15 months of FDA order
– Devices subject to postmarket surveillance:
failure would reasonably have serious adverse health consequences
significant use in pediatric populations
intended to be implanted for more than 1 year
life-sustaining or life-supporting (used outside a device user facility)
26
27. www.duanemorris.com
Medical Devices …
• Mobile Apps – FDA required to issue a report by
January 9, 2014 on a proposed strategy and
recommendations for a risk-based approach to health
information technology
– must consult with FCC and the National Coordinator for
Health Information Technology (within HHS) in preparing
report
• Laboratory Developed Test (LDTs) – FDA must
notify Congress at least 60 days prior to issuing a draft or
final guidance on LDTs
27
28. www.duanemorris.com
Electronic Submissions
• Drugs – to be required no earlier than 24 months after
FDA issues a final guidance – applies to: INDs, NDAs,
ANDAs, BLAs (including biosimilar apps.)
• Devices – applies to 510(k)’s, PMAs, IDEs, and a
number of other device submissions
– after a guidance document is finalized
– language is “shall include” an electronic copy, which implies it
can still be submitted in paper format
28
29. www.duanemorris.com
Miscellaneous Provisions
• Internet & Social Media – FDASIA § 1121 orders FDA
to issue guidance on its policy on the use of the internet,
including social media, in promoting medical products --
due by July 2014
• Acceptance of Foreign Data – new § 569B – FDA
must accept if applicant shows that data are adequate to
support approval, clearance or licensing; or
– FDA must notify sponsor of rationale why data are not OK
• Conflicts of Interests – loosened § 712 to allow FDA
advisory committees to have better access to experts
29
31. www.duanemorris.com
FDA Reorganizations
• Center for Drugs – FDA considering:
– Generics – to be a “super” office reporting directly to Woodcock
– Office of Pharmaceutical Quality – entire lifecycle view
• Office of Device Evaluation – 2 new review divisions:
– Surgical Devices
– Neurological and Physical Medicine Devices,
– Existing five divisions are:
Anesthesiology, General Hospital, Infection Control, and Dental
Cardiovascular –
is now handling 30-day notices on changes that were in CDRH Office of
Compliance
Surgical, Orthopedic, and Restorative
Ophthalmic, Neurological, and ENT
Reproductive, Gastro-Renal, and Urological
32. www.duanemorris.com
FDA Reorganizations …
• OIVD – now OIR – Office of In Vitro Diagnostics
and Radiological Health -- covering radiological and
mammography devices both for market clearance and
post-marketing roles
• CDRH Compliance Office – going to 5 divisions
– Adding International Compliance Operations Division
– Adding Premarket and Labeling Compliance Division
– Combining two enforcement divisions into a Division of
Manufacturing Quality
– Bioresearch Monitoring (BIMO)
– Risk Management Operation
32
33. www.duanemorris.com
FDA Reorganizations …
• Office of Regulatory Affairs – FDA “Top Cop”
– Dara Corrigan – current head – to Brussels to head FDA’s
European office and be Senior Advisor for Global Operations
– creating Office of Operations – with oversight over:
folding 4 existing offices (Enforcement, Regional Ops, and
Domestic Field Investigations, & Foreign Field Investigations)
into 3 new ones:
Office of Food and Feed Operations
Office of Medical Products and Tobacco Operations
Office of Enforcement and Import Operations (OEIO)
– new Office of Policy & Risk Management
– no impact on field structure
33
34. www.duanemorris.com
Hurricane Sandy and IRBs -- OHRP
• HHS Office of Human Research Protection –e-mail
November 13 -- expressing flexibility on situations where
IRBs cannot function due to Sandy. Key issues:
– Continuing review for expiring research:
Ideally – refer research to another IRB for continuing review
But, what if not possible and prior IRB approval expires:
Refer to another IRB (if records accessible)
If not possible to refer, “expired” research can continue if in best
interests of subject
– May subjects be treated elsewhere at a facility that lacks
an FWA or IRB – research can be done if in best interests of
subject
34
35. www.duanemorris.com
Questions?
• Call, e-mail or fax:
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
San Diego, California
direct: 619-744-2215
fax: 619-923-6248
maswit@duanemorris.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
35
36. www.duanemorris.com
About Your Speaker
Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law
firm, Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges
faced by highly-regulated pharmaceutical, medical device and food companies. Before joining
Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg
Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His
expertise includes product development, compliance and enforcement, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and
advertising, and clinical research efforts for all types of life sciences companies, with a
particular emphasis on drugs, biologics and therapeutic biotech products. Mr. Swit has been
addressing vital FDA legal and regulatory issues since 1984, both in private practice with
McKenna & Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of
Par Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994 to
1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty
information products for FDA-regulated firms. He has taught and written on many topics
relating to FDA regulation and associated commercial activities and is a past member of the
Food & Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high
honors in history, at Bowdoin College, and his law degree at Emory University.
36