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# Industry Explains PDUFA 8 Facility Lifecycle Counterproposal
- URL: https://www.fdaweb.com/industry-explains-pdufa-8-facility-lifecycle-counterproposal/
- Published: 2026-02-05T12:00:00.000Z
- Updated: 2026-09-14T15:32:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160615

At the 1/6 meeting of the PDUFA 8 CMC Subgroup, industry representatives explained their counterproposal to FDA’s facility lifecycle proposal. The meeting [minutes](https://www.fda.gov/media/190957/download?attachment&ref=fdaweb.com) indicate that industry proposed a timeline for communications associated with the form FDA-483 that is issued after a pre-approval inspection. The minutes say agency representatives raised concerns around receiving a substantive 483 response from firms to address significant facility issues because there is not enough time for those issues to be resolved within the review cycle. The two sides reportedly agreed that outlining a way to put boundaries around post-inspection meetings or a gatekeeping strategy was necessary to ensure that the PDUFA resources are used efficiently and post-inspection meetings are meaningful to resolve facility issues.

Industry also proposed a pre-submission meeting at which FDA and the sponsor would discuss the manufacturing site and potential inspection-related issues. The agency questioned the industry perspective on the timing and expectation for discussion at the pre-submission meetings.

Finally, industry proposed CMC (chemistry, manufacturing, and controls)-related commitments regarding communication for inspection-related issues during the review cycle. FDA reiterated that the existing PDUFA 7 commitment related to communicating the timing for pre-license inspections applies only when it is necessary to see manufacturing occurring.