Thanks for this Aditi, helpful information. You can also get on the FDA's listserv or mailing list to get regular email updates which includes publications of guidance documents, webinars, and proposed regulations. These are usually specific to an area or branch, like CDRH, but the link shown can see and filter through all of the proposed regulations. And yes commenting on proposed regulations does help because the US FDA are required to read through them and address as appropriate.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Oct-2023 11:55
From: Aditi Khurana
Subject: Making your voice heard at FDA
As a member of the Regulatory Community and profession have you ever wondered about how to get your voice heard at FDA? I was curious about this and discovered some resources to share with the community. This FDA webpage gives general information on how to provide comments to open guidances or proposed rules. Comment on Proposed Regulations and Submit Petition
You can also go to Regulations.gov and search from FDA documents and will notice that there are several documents open for public comment. Listing some of these below if anyone is interested:
FDA-2023-N-4489-0001 Enhancing Adoption of Innovative Clinical Trial Approaches; Public Workshop; Request for Comments
FDA-2023-N-2462-0001 Workshop to Enhance Clinical Study Diversity; Request for Comments
FDA-2023-D-2318-0003 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry
FDA-2023-D-2482-0002 Regulatory Considerations for Prescription Drug Use- Related Software Guidance for Industry
FDA-2023-N-3721-0001 Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments
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Aditi Khurana
Director, PM
Newark CA
United States
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