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Posted: 09/21/2023
FDA issues revised draft guidance on formal meetings for PDUFA products
The draft guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products. This draft guidance describes the different meeting types, formats, and timelines associated with those requests. It also provides industry with the information necessary to have a complete meeting request and background package to help facilitate the meeting to gain useful feedback for product development. The draft guidance provides examples to help guide stakeholders on selecting and requesting the proper meeting type for a given scenario.
Comments regarding this draft guidance should be submitted following the information in the notice of availability that will be posted in the Federal Register shortly.
 Call for Submissions!
FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Meeting Program is accepting RDEA proposals for this quarter until September 30, 2023. The RDEA Pilot Meeting Program is designed to support novel endpoint efficacy development for drugs that treat rare diseases by providing a mechanism for sponsors to collaborate with FDA throughout the efficacy endpoint development process. The RDEA Pilot Meeting Program provides an opportunity for sponsors whose proposals are admitted to the program to interact with FDA experts at up to four meetings designed specifically to discuss their proposed novel endpoint.
RDEA proposals may be submitted on a rolling basis and must be received by the last calendar day of each quarter.
Quarterly proposal submission deadlines:
- March 31
- June 30
- September 30
- December 31
For more information about the program and how to submit an RDEA proposal, please see the recently updated RDEA Pilot Program webpage and the RDEA Pilot Program Frequently Asked Questions webpage.
Request for Comments
Draft Guidance on Manufacturing Changes
New draft guidance on manufacturing changes and comparability for human cellular and #GeneTherapy products. Listen to this recorded webinar for a high-level overview and submit comments to the docket by November 13, 2023: https://bit.ly/3PfJQSX
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