Industry Pushes for Automatic Post-Inspection Meetings and Faster FDA Response Times
What the January CMC subgroup discussions reveal about potential changes to the Form 483 process amid PDUFA VIII negotiations.
Representatives from the pharma industry want the FDA to commit to automatic post-inspection meetings whenever a Form 483 is issued following a Pre-Approval Inspection, and to respond to 483 responses within 15 days.
These proposals emerged during a January 6 meeting of the PDUFA VIII CMC subgroup, where industry representatives from PhRMA, BIO, Eli Lilly, and Alkermes presented their counterproposal to the FDA’s facility lifecycle framework.
The meeting minutes, recently made public, give us a window into how the industry and the FDA are negotiating the terms of the next user fee reauthorization cycle covering fiscal years 2028–2032.
Let’s break it down quickly.
What industry is proposing
The counterproposal here centers on creating defined timelines and touchpoints around Form 483 communications after pre-approval inspections. More specifically:
15-day response windows: Companies would have 15 days to respond to 483 observations (consistent with current practice), but the FDA would also be required to respond within 15 days of receiving the company’s response. Currently, there’s no such reciprocal timeline for the agency.
Automatic post-inspection meetings: Whenever the FDA issues a Form 483 following a PAI, a meeting would be automatically scheduled. The industry’s stated goal is to get more clarity on which observations will create approvability issues and to understand the path to remediation before the agency takes an action.
Pre-submission facility discussions: The industry also proposed a meeting format where sponsors could discuss manufacturing sites and potential inspection-related issues with the FDA prior to submission, sharing facility information to support the agency’s risk-based inspection approach.
Day 74 letter enhancements: The proposal asks that Day 74 letters include dates for interim milestones and known dates for any GMP or GCP inspections occurring during the review cycle.
The FDA’s response and concerns
The agency acknowledged the counterproposal but brought up what it saw as a few practical concerns during the discussion.
On the automatic meeting proposal, the FDA pointed out that not every Form 483 results in a Complete Response Letter. The current process already allows minor issues to be resolved without necessitating a meeting. The FDA was concerned about receiving substantive 483 responses that could actually address significant facility issues, noting that there often isn’t enough time to resolve complex facility problems within the review cycle.
Both sides agreed that any post-inspection meeting commitment would need clear boundaries or “gatekeeping” criteria to make sure that PDUFA resources are used efficiently and that meetings focus on issues that can actually be resolved.
At the pre-submission meeting proposal, the FDA questioned the industry about the expected timing and scope of these discussions.
Regarding the Day 74 letter enhancement, the FDA reiterated that existing PDUFA VII commitments around communicating pre-license inspection timing apply only when it’s necessary to observe manufacturing in operation.
The underlying problem the industry wants to solve
Reading between the lines of the meeting minutes here, it seems pretty clear to us that the industry’s core concern is predictability. Specifically, wanting earlier and clearer communication about which 483 observations will affect approvability.
Industry reps acknowledged this proposal won’t resolve complex facility issues within the first review cycle in all cases. But they argued that even a modest reduction in CRLs related to inspection issues would be significant.
More importantly, they emphasized that even when timely remediation isn’t possible, clarity on the issues would help sponsors plan their path forward.
What this might mean for manufacturers
These negotiations are still early. Another meeting was held on January 13, focused on the FDA providing feedback on the industry’s counterproposal (meeting minutes not released yet), and the full commitment letter won’t be finalized until later this year.
If industry’s proposals gain traction here, manufacturers could see more structured timelines around PAI-related communications and potentially earlier insight into which facility issues will require resolution before approval. The pre-submission facility meeting concept (if adopted) could create a new touchpoint for more proactive engagement on manufacturing site readiness.
But the FDA’s concerns about resource constraints and the practical limits of what can be resolved during a review cycle suggest the final commitments will likely include significant guardrails around when and how these mechanisms apply.
The push for automatic post-inspection meetings does reflect a real pain point we see with clients: the uncertainty between receiving a 483 and understanding whether those observations will actually block approval. That gap (not knowing which findings are "nice to fix" versus "must fix before approval") can sometimes create a sort of planning paralysis, especially for companies managing complex global supply chains or contract manufacturing relationships.
That said, automatic meetings likely aren’t a silver bullet solution here. The value of any post-inspection meeting depends so much on the FDA having enough information to provide meaningful feedback—and that means your 483 response needs to be substantive, not just acknowledging the observations. Companies that treat the 15-day response window as a box-checking exercise won't get much out of a follow-up meeting regardless of whether it's automatic.
The more interesting proposal here may be the pre-submission facility discussion concept. For sponsors with manufacturing complexity (new facilities, novel processes, or sites with compliance history), aligning with the FDA on inspection priorities before the clock starts could be genuinely valuable. (Whether the FDA has the bandwidth to offer this at scale is another question!)
We’ll continue tracking these negotiations as the PDUFA VIII commitment letter takes shape. The current user fee programs expire September 30, 2027.
Read the FDA and Industry CMC Subgroup meeting minutes »
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