FDA Policy/General

FDA Preparing for Drug User Fee Negotiations

FDA is preparing to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires 9/2027. A new notice is seeking public stakeholders — patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — to participate in periodic consultation meetings. The agency is initiating the reauthorization process by holding a public meeting on July 14, 2025, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization, according to the notice.

The Federal Food, Drug, and Cosmetic Act mandates that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. It also requires that the agency hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with regulated industry.

After recent reduction-in-force cuts at FDA eliminated most of the staff who worked on PDUFA, the agency has begun rehiring some of the personnel to help prepare for the upcoming work. This behind-the-scenes notice is also a positive sign from the Trump administration and their likely intent to extend the program beyond 2027. Previously, HHS secretary Robert F. Kennedy, Jr. repeatedly questioned the program because HE it makes the agency beholden to the drug industry.

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