Draft Guidance: FDA Issues Two Draft Guidances - Post-Approval Study Reqs and Postmarket Surveillance

Comments due by July 26, 2021 on these two new draft guidances.

If your email program has trouble displaying this email, view as a webpage. The FDA Issues Two Draft Guidances on Post Approval Study Requirements and Section 522 of the Food, Drug, and Cosmetic Act Today, the U.S. Food and Drug Administration (FDA) issued two draft guidances to provide updates on post-approval study requirements and postmarket surveillance studies. Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order This guidance includes: Procedural Information. Recommendations concerning the format, content, and review of post-approval study (PAS)-related submissions. Recommendations to help facilitate the FDA's review of a PAS protocol in a timely manner. Recommendations for study timelines including enrollment milestones and study completion. Revised definitions to PAS status categories that we believe better reflect progress of the PAS. Revised FDA review time goals for PAS-related submissions. When final, this guidance will supersede Procedures for Handling Post-Approval Studies Imposed by PMA Order, issued on June 15, 2009. Read the Draft Guidance Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) This guidance includes: An overview of section 522 of the FD&C Act. Information on how to fulfill section 522 obligations, including: when postmarket surveillance should be considered commenced; recommendations for achieving an approved postmarket surveillance plan in a timely manner; and recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance; Recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions. Updated surveillance status categories to better reflect progress. When final, this guidance will supersede Postmarket Surveillance Under Section 522 of the FD&C Act, issued on May 16, 2016. Read the Draft Guidance Submit comments on these draft guidances Both draft guidances will be open for public comments for 60 days at www.Regulations.gov. Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act under docket number FDA-2011-D-0514. Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order under docket number FDA-2005-D-0027. Questions? If you have questions about these draft guidances, please contact the Office of Product Evaluation and Quality/Office of Clinical Evidence and Analysis/Division of Clinical Science and Quality (OCEA) at MandatedStudiesPrograms@fda.hhs.gov.

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