Drugs

FDA Clarifies Compounded GLP-1 Enforcement

FDA says it has not changed its intentions on enforcement discretion for drug compounders as the national GLP-1 (glucagon-like peptide-1) supply begins to stabilize. An agency statement says the timeframes during which it does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) arising from conditions that depend on tirzepatide (Lilly’s Zepbound and Mounjaro) products’ inclusion on the FDA drug shortage list. The timeframes are:

for a state-licensed pharmacy or physician compounding under Section 503A of the FFDCA until 2/18 or until the date of a Texas federal court’s decision on the plaintiffs’ preliminary injunction motion in Outsourcing Facilities Association v. FDA, whichever is longer; and
for outsourcing facilities under Section 503B until 3/19 or until the date of a Texas federal court’s decision on the plaintiffs’ preliminary injunction motion in Outsourcing Facilities Association v. FDA, whichever is longer.

“FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be on substandard quality or otherwise unsafe,” the notice says.

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