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
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
This document discusses guidelines for pharmacovigilance (PV), which is the monitoring of drugs for safety issues. Some key points:
- Clinical trials must have strict ethics and safety protocols to protect subjects and maintain trust. Post-approval monitoring is also important.
- Marketing authorization holders are responsible for PV of their approved drugs. This includes reporting safety issues, having a qualified person responsible for PV, and maintaining a detailed PV system.
- Competent authorities conduct inspections to ensure marketing authorization holders follow PV requirements. They also monitor for safety signals and ensure timely communication of issues.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
The document discusses FDA acceptance of foreign clinical trial data for regulatory submissions. It provides an overview of current regulations and considerations for both IND and non-IND studies conducted abroad. Key points include that foreign data is acceptable if studies meet good clinical practices and are applicable to the US population. While IND studies must follow all US rules, non-IND studies require proof of GCP compliance and complete documentation for FDA to consider acceptance. Practical and scientific issues in extrapolating results from foreign to US populations are also addressed.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
This document discusses guidelines for pharmacovigilance (PV), which is the monitoring of drugs for safety issues. Some key points:
- Clinical trials must have strict ethics and safety protocols to protect subjects and maintain trust. Post-approval monitoring is also important.
- Marketing authorization holders are responsible for PV of their approved drugs. This includes reporting safety issues, having a qualified person responsible for PV, and maintaining a detailed PV system.
- Competent authorities conduct inspections to ensure marketing authorization holders follow PV requirements. They also monitor for safety signals and ensure timely communication of issues.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
The document discusses FDA acceptance of foreign clinical trial data for regulatory submissions. It provides an overview of current regulations and considerations for both IND and non-IND studies conducted abroad. Key points include that foreign data is acceptable if studies meet good clinical practices and are applicable to the US population. While IND studies must follow all US rules, non-IND studies require proof of GCP compliance and complete documentation for FDA to consider acceptance. Practical and scientific issues in extrapolating results from foreign to US populations are also addressed.
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
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document discusses the regulatory process for electronic submissions to regulatory authorities. It is divided into four steps - planning, document preparation, publishing the dossier, and submission. It provides guidance on tools for planning like checklists, templates, and timelines. It also discusses the eCTD format, FDA Electronic Submissions Gateway for submitting to FDA, and validation checks. Non-eCTD electronic submissions and ACTD format are also summarized.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The Office of Combination Products (OCP) classifies 9 types of combination products based on their constituent parts and primary mode of action. Combination products are assigned to the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), or Center for Devices and Radiological Health (CDRH) based on whether their primary mode of action is provided by a drug, biological product, or medical device. OCP provides guidance on submitting Request for Designations and classifying new combination products.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
EU Clinical Regulation Webinar Slide Deck.pptxMMS Holdings
The webinar discusses key changes introduced by the new EU Clinical Trials Regulation that will revolutionize clinical trial transparency in Europe. Some of the major changes include a single application portal, expanded data disclosure requirements, and public access to clinical study documents and results. The new regulation aims to streamline the application process and increase oversight and transparency of clinical trials conducted in the European Union.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
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, March 22, 2018
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
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
The document discusses the regulatory process for electronic submissions to regulatory authorities. It is divided into four steps - planning, document preparation, publishing the dossier, and submission. It provides guidance on tools for planning like checklists, templates, and timelines. It also discusses the eCTD format, FDA Electronic Submissions Gateway for submitting to FDA, and validation checks. Non-eCTD electronic submissions and ACTD format are also summarized.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
The Office of Combination Products (OCP) classifies 9 types of combination products based on their constituent parts and primary mode of action. Combination products are assigned to the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), or Center for Devices and Radiological Health (CDRH) based on whether their primary mode of action is provided by a drug, biological product, or medical device. OCP provides guidance on submitting Request for Designations and classifying new combination products.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
EU Clinical Regulation Webinar Slide Deck.pptxMMS Holdings
The webinar discusses key changes introduced by the new EU Clinical Trials Regulation that will revolutionize clinical trial transparency in Europe. Some of the major changes include a single application portal, expanded data disclosure requirements, and public access to clinical study documents and results. The new regulation aims to streamline the application process and increase oversight and transparency of clinical trials conducted in the European Union.
Abriviated new drug application 505(j) fillingshahnawazQuadir
An abbreviated new drug application (ANDA) allows generic drug manufacturers to file for FDA approval of a generic drug. The ANDA relies on the safety and efficacy data of an approved innovator drug and must demonstrate bioequivalence through bioavailability/bioequivalence studies. There are different types of ANDA applications including Paragraph I, II, III, and IV, with Paragraph IV applications being used when a generic applicant is attempting to enter the market before patent expiration by claiming the patents are invalid or would not be infringed by the generic product. The ANDA review process involves a 30 month stay if the innovator sues for patent infringement within 45 days, during which time the first approved generic receives 180 days of market
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
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, March 22, 2018
FDA Regulation of Direct-to-Consumer AdsMichael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
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 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
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
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.
Import and export regulations laws of usaSanjay Yadav
This document discusses FDA regulations regarding the import and export of medical products. It outlines the authorities FDA has to examine imported foods, drugs, and other products. It provides details on import documentation and entry requirements. It also discusses requirements for exporting over-the-counter drugs and unapproved new drugs in accordance with Section 802 of the Federal Food, Drug, and Cosmetic Act.
FDA Regulation of Promotion & Advertising Part 7: FTC RegulationMichael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
FDA DTC Television Ad Review Program-The 45-Day ClockPALIO
The document discusses the FDA's 45-day review process for direct-to-consumer television advertisements of prescription drugs, as required by the FDAAA. It outlines the six categories of ads subject to mandatory pre-dissemination review, consequences for noncompliance, and what sponsors can do if the FDA does not provide comments within 45 days. While the guidance only applies to television ads, the document notes there may still be issues with disseminating similar ads online without FDA review. It recommends developing social media strategies within FDA guidelines.
TGA Presentation: Therapeutic Goods Advertising Code (No. 2) 2018TGA Australia
The document provides background information on Australia's Therapeutic Goods Advertising legislation and Code. It discusses key aspects of the legislation including:
- The Therapeutic Goods Act and Regulations set advertising requirements for therapeutic goods. Advertising must also comply with the Australian Consumer Law.
- The Act prohibits off-label promotion and requires pre-approval of medicine ads in certain media. It also places restrictions on advertising certain medical conditions.
- The Therapeutic Goods Advertising Code provides the framework for ensuring advertising is conducted properly and does not mislead consumers. It was recently revised to provide more clarity.
- The Code applies broadly to any advertising of therapeutic goods. It exempts genuine news reporting and ads directed to health
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
The document discusses DRAP's implementation of the Common Technical Document (CTD) format as the standard dossier for drug product registration applications in Pakistan beginning January 1, 2019. The CTD format was developed by international regulatory agencies to harmonize technical documents for new drug approvals. It aims to standardize information and reduce delays in the review process. The document outlines the history and purpose of the CTD, as well as the regions that have adopted it. It provides an overview of the five CTD modules and the key administrative information required in Module 1 for DRAP registration applications.
TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code ...TGA Australia
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by a detailed walkthrough of the Code with examples to illustrate the application of the key sections. Information about which version of the Code will apply to advertisements for the purposes of advertising pre-approval and complaints handling is also provided.
Regulations on Medical Device Excise Tax Proposed; Opportunities for CommentPatton Boggs LLP
The IRS and Treasury Department released a proposed rulemaking addressing the 2.3% excise tax imposed on medical device sales. The proposal defines taxable devices, provides an exemption for retail purchases, and outlines how existing manufacturer tax rules apply. A public hearing will be held in May to discuss the proposal, which does not address all raised issues such as treatment of vertically integrated companies. Medical device companies should analyze which products are taxable and comment on the proposal.
A French or European pharmaceutical or medical device company seeking to enter the US market must consider several important structural and legal factors. They will need to understand FDA regulations for drugs, devices and clinical trials. They must also consider liability issues, intellectual property protections, commercial agreements, corporate structures like LLCs vs corporations, employment laws, immigration rules, and potential acquisitions in the US. Setting up a US subsidiary is often a good option to gain a foothold in the market after initiating direct sales. Consulting with legal experts is important for properly addressing these various issues.
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This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
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