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Pmr Regulations

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The 1997 Food and Drug Administration Modernization Act (FDAMA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to include several new provisions added by Congress. One provision is the requirement that sponsors of approved drugs and biological products, report on the progression of Post Marketing Requirements (PMR) and Post Marketing Commitments (PMC) annually. Section 506B of FDCA authorizes the FDA to track and monitor the progress of PMR/PMC to ensure completion in a timely manner. FDA accomplishes this task by reviewing Annual Status Reports (ASRs) submitted by the sponsor for completeness and accuracy. Sponsors of approved drugs and biological products that have entered into an agreement to conduct a post marketing study or trial …show more content…
The decision and rationale whether Post Marketing Requirements (PMR) or Post Marketing Commitments (PMC) will be required from the product sponsor occurs prior to FDA application approval. The underlying reasons why the FDA may require additional studies or trials from the product sponsor are to assess known serious risks, signals of serious risks, and identify unexpected serious risks. PMRs are required by statue or regulation, while PMCs are written agreements between the FDA and the sponsor but isn’t required by law. The FDA has the ability to issue an enforcement action against a product sponsor if they are in violation of their PMRs. The enforcement action options available to the FDA are civil monetary penalties, misbranding charges, or charges under section 505 (Removal of the product from the …show more content…
Prior to the initiation of the study or clinical trial, the product sponsor is responsible for submitting the final protocol for FDA review. Upon receipt of the final protocol, the FDA has 30 days to review and suggest improvements if needed. In addition, once the product sponsor initiates the study or clinical trial, they should notify the FDA or include the information in the Annual Status Report (ASR). On an annual basis until notified by the FDA, the product sponsor is responsible for submitting an ASR to the FDA within 60 days of application approval date. Once the ASR is received, the FDA has 3 months to review and respond to the product sponsor. Upon completion of the study or clinical trial the product sponsor is responsible for notifying the FDA as well as submitting the final report. Upon receipt of the final report, the FDA has 12 months to review and respond to the product sponsor. The product sponsor is only completed with their PMRs/PMCs once the final report has been reviewed by the FDA and a PMR/PMC fulfillment letter is

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