Drugs

PDUFA 8 Negotiations on RWE, First-Cycle Reviews

Representatives of FDA and the drug industry made progress on PDUFA 8 negotiations on real-world evidence (RWE) and first-cycle reviews at the 12/9/2025 FDA/Industry Premarket Subgroup session. According to the meeting minutes, on real-world evidence FDA recommended that the pilot be continued in PDUFA 8 since there has not been adequate experience from the pilot to transfer into standard review practice. The agency expressed a concern that without a dedicated pilot program, the use of RWE in regulatory decision-making would decline.

FDA asked whether industry would continue to fund the 35 full-time equivalents (FTEs) for PDUFA 8 and expressed that the agency could use PDUFA resources for training programs, given interest in this area.

Industry asked questions about how many of the FTEs are RWE experts and whether FDA would be willing to document in a checklist that RWE was used in decision-making. FDA asked for industry clarification on how FTEs should be distributed and if industry would be open to FDA making changes to the pilot program based on industry’s concerns.

Regarding the approach to facilitate first-cycle reviews, FDA said it does not agree with the industry proposal to incorporate tracked metrics for protocol review timelines. The agency said industry had not presented data that the timing of FDA review and responses to IND protocols contribute to regulatory actions taken for subsequent marketing applications. It also presented its root cause analysis of complete response actions. It said the preliminary root cause analysis did not provide evidence that timelines for review of protocols under the IND contributed to complete response actions at the NDA/BLA stage.

The agency proposed working with industry on questions for a third-party assessment on reasons for CRLs, communications between FDA and sponsors during the IND phase on potential deficiencies, and the impact of using new tools to facilitate protocol and protocol amendment reviews. The assessment would inform whether process changes should be undertaken in the middle of PDUFA 8.

FDA and industry agreed to continue discussing the Facilitate First-Cycle Reviews proposal. The agency agreed to provide a response to industry’s concern that protocol delays result in development delays.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome