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# Topics Discussed at 2 PDUFA 7 Pre-Market Subgroup Meetings
- URL: https://www.fdaweb.com/topics-discussed-at-2-pdufa-7-pre-market-subgroup-meetings/
- Published: 2021-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:55:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149145

FDA and industry negotiators met 1/21 and 1/27 to continue discussions on proposals from each side to enhance the review process. The sides acknowledged the need to continue discussing overall proposed resource requests at future negotiation meetings.

The 1/21 [meeting summary](http://www.fda.gov/media/147564/download?ref=fdaweb.com) lists these topics that were discussed: advancing development of efficacy endpoints for rare disease; FDA/sponsor interactions (meeting management); real-world evidence; use-related risk analysis and human factor protocol review; bioinformatics review expertise; and innovative review approaches: split real-time application review.

Topics discussed at the 1/27 [session](http://www.fda.gov/media/147552/download?ref=fdaweb.com) were new molecular entity milestones and postmarketing requirements; advancing development of efficacy endpoints for rare disease; use-related risk analysis and human factor protocol review; and innovative review approaches: split real-time application review.