Topics Discussed at 2 PDUFA 7 Pre-Market Subgroup Meetings

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 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 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.