Drugs

Follow Law on Advisory Committees: Petition

The National Association of Manufacturers (NAM) is petitioning FDA to follow the statutory and regulatory procedures governing advisory committees under regulations and the Federal Advisory Committee Act “to allow for mandatory and all other stakeholders to comment on current and upcoming regulatory policies and procedures that FDA is discussing during the agency’s advisory committee expert panels.” The 3/24 petition says manufacturers strongly support the administration’s efforts to advance a pro-growth agenda for manufacturing in the U.S., including initiatives to reduce unnecessary regulatory burdens and enhance transparency in the regulatory process.

But, it says, to enhance transparency and encourage scientific rigor, NAM asks that the public receive timely and proper notice before advisory committee meetings are held, and the establishment of an open docket, to be made available on the Federal Register, that allows for the submission of public comments pertaining to the subject matter of these advisory committee expert panels.

The petition notes a statement made by FDA commissioner Marty Makary in 2025 at the Food and Drug Law Annual Conference that FDA would not “go through the bureaucracy of a FACA (Federal Advisory Committee Act)” when organizing expert panels in his effort to “rethink” existing procedural processes.

It specifically asks that FDA use the Federal Register to open a docket that provides notice of expert panel meetings and the opportunity to provide comments relevant to the issues discussed by the expert panelists.

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