PDUVA VIII: Industry seeks automatic post-inspection meetings after receiving a 483
The pharmaceutical industry groups are suggesting that the US Food and Drug Administration (FDA) automatically schedule a post-inspection meeting whenever it issues a Form 483 to manufacturers following a preapproval inspection (PAI). Additionally, industry is requesting that FDA respond within 15 days after receiving companies' responses to the Form 483.At present, the FDA does not automatically hold a post-inspection meeting after issuing a Form 483 to sponsors. Also, while companies are generally required to respond to the agency within 15 days of receiving a Form 483 report, there is no similar requirement for the agency to respond.
These recommendations were proposed by the industry during negotiations to renew the user fee program under the Prescription Drug User Fee Act (PDUFA VIII) for fiscal years 2028 to 2032. This proposal was mentioned in the meeting minutes from the PDUFA discussions held with industry representatives on January 6.
Most of FDA's user fee programs, which include those for prescription and generic drugs, medical devices, and biosimilars, are scheduled to expire on 30 September 2027.
The meeting included representatives from the FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER). On the industry side attendees included representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), Eli Lilly, and Alkermes.
The purpose of the meeting was to review details of the industry’s counterproposals to the FDA’s facility lifecycle proposal.
During the meeting, the industry proposed a timeline for FDA communication to sponsors following the issuance of a Form 483 that occurs after a PAI.
Industry said the purpose of these proposals is “to gain clarity on issues cited in FDA Form 483 that will lead to approvability issues and their ability to remediate those issues prior to an action from the Agency or down the road.”
In response, FDA said that not every FDA Form 483 leads to a Complete Response Letter (CRL), and the current process permits minor issues to be addressed without necessitating a meeting.
Industry responded that even a slight decrease in CRLs would be significant. Additionally, even when there is no clear path for timely remediation, understanding the issues would still benefit the sponsor.
The industry and FDA agreed on the need to establish boundaries for post-inspection meetings to ensure that PDUFA resources are used efficiently and that post-inspection meetings effectively address facility issues.
Industry also proposed a pre-submission meeting to discuss the manufacturing site and potential inspection-related issues with the FDA and sponsors. In response, the FDA questioned the timing and expectations for discussions during the pre-submission meetings.
Minutes
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