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# PDUFA Reauthorization Pre-market Talks
- URL: https://www.fdaweb.com/pdufa-reauthorization-pre-market-talks/
- Published: 2021-02-24T12:00:00.000Z
- Updated: 2026-09-14T16:48:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148735

FDA has posted summaries of the 12/9/20 and 12/16/20 meetings of the FDA/industry pre-market subgroup that is part of discussions on the PDUFA 7 reauthorization. The 12/9 [meeting](http://www.fda.gov/media/146126/download?ref=fdaweb.com) covered: 

- further discussions about a real-world evidence pilot program to increase the use of real-world data during application review and in regulatory decision-making;
- continued discussions about a proposal to improve timely discussions of postmarketing studies during the application review process and discussion of a proposal to establish a mechanism for engaging senior Center leadership in disagreements about the feasibility of existing postmarketing requirements;
- industry will respond to an FDA counterproposal for establishing and communicating best practices related to PDUFA meeting management, establish a novel type of formal meeting, and formalizing CBER’s INTERACT program while establishing a similar CDER program;
- industry to provide feedback on an FDA counterproposal for a pilot program to expand the split submission and review of required sections of marketing applications to additional product types and review disciplines outside of oncology; and
- continued discussions about a proposal to enhance CBER and CDER expertise in various aspects of bioinformatics to support FDA’s ability to provide detailed and consistently timed feedback to industry earlier in the development cycle.

The 12/16 [meeting](http://www.fda.gov/media/146127/download?ref=fdaweb.com) covered: 

- continued discussions about a proposal to improve timely notification of postmarketing requirements during the marketing application review process;
- industry asked FDA to establish timelines for conducting the Active Risk Identification and Analysis sufficiency determination and FDA said including timelines in a PDUFA commitment would likely not be feasible due to variable safety evaluation timelines;
- continued discussions on a real-world evidence pilot project with FDA agreeing to provide additional details on resources potentially required to establish and maintain a pilot program;
- continued discussions about a proposal to enhance the review of human factor protocols and use-related risk analyses submitted by sponsors, especially during combination product development programs, with FDA clarifying its original proposal;
- continued discussions on an FDA counterproposal for a Split Real-Time Application Review pilot program that would expand the split submission and review of required sections of marketing applications to additional product types and review disciplines outside of oncology, with FDA providing additional details on resources potentially needed; and
- FDA clarifying questions about industry’s written feedback on an agency counterproposal for establishing and communicating best practices related to PDUFA meeting management.