Drugs

First Cycle Review Metrics Debated at PDUFA Session

Minutes from the 12/2/2025 meeting of the PDUFA Reauthorization FDA and Industry Premarket Subgroup show the two sides debated metrics on agency first-cycle review times and goals. At an earlier meeting, industry representatives had presented data supporting their Facilitate First Cycle Review proposals. Session minutes show that FDA indicated that it had successfully incorporated and implemented the program agreed to in the PDUFA 7 commitment letter, based on meeting and often exceeding the performance goals.

FDA also challenged the industry’s assertions that the first-cycle approval rate had decreased and the first-cycle complete response letter (CRL) rate had correspondingly increased.

FDA representatives said they do not agree with the industry’s overall proposal for Facilitate First Cycle Reviews because there are no data to support the assertion that the agency has not been meeting program objectives.

The industry representatives said the current CRL rate is not achieving the stated goal in PDUFA 7 of promoting the efficiency and effectiveness of the first cycle review process and minimizing the number of review cycles necessary for approval. They said the industry expects to see more efficiencies in the review process.

Ultimately, FDA asked for clarification on what problem industry was trying to solve, and industry responded that it is trying to address information requests late in the review cycle leading to delays, including CRLs. FDA agreed to review industry’s counterproposal on tracked metrics in further detail and respond at a future meeting.

The sides also discussed the agency’s model-informed drug development (MIDD) proposal and began negotiating FDA’s rare disease proposal. The sides tentatively agreed on the value of the MIDD program and will move the discussion of resources to the Finance subgroup. The sides agreed to continue discussing the rare disease proposal and what the Rare Disease Innovation Hub provides, and to consider the resources needed for the rare disease proposal.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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