> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# PDUFA 7 Reauthorization Meeting Notes
- URL: https://www.fdaweb.com/pdufa-7-reauthorization-meeting-notes/
- Published: 2021-02-03T12:00:00.000Z
- Updated: 2026-09-14T16:45:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148591

FDA has released notes from three workgroup and subgroup meetings as part of PDUFA 7 reauthorization discussions between the agency and industry representatives:

- **Manufacturing and Inspections Workgroup**, 11/18/20\. The [meeting](http://www.fda.gov/media/145368/download?ref=fdaweb.com) focused on finalizing discussions at the subgroup level for industry proposals relating to pre-approval/pre-licensure inspections waivers, application content versus inspection content, and announced pre-approval/pre-licensure inspections.
- **Postmarket Subgroup**, 12/2/20\. The [meeting](http://www.fda.gov/media/145562/download?ref=fdaweb.com) discussed REMS assessments and explored possible options for increasing the review process efficiency, including adjusting the time interval for REMS assessments. FDA agreed to take questions on timing and process to agency REMS experts. The participants also discussed FDA’s proposal on Sentinel and pregnancy safety. There also was a brief discussion of the use of Sentinel analytics and health outcomes of interest.
- **Postmarket Subgroup**, 12/9/20\. The [session](http://www.fda.gov/media/145564/download?ref=fdaweb.com) had a more detailed discussion of FDA’s REMS assessment proposal and its Sentinel proposal, including the possibility of Sentinel demonstration projects using analytics and the pregnancy safety project. The parties agreed that the subgroup is making good progress. FDA and industry have both shared their proposals, including resource estimates. Members expressed satisfaction that the discussions were focusing on specific aspects of the proposals and specific resource needs.