Drugs

FDA Clarifies Compounding Policy for GLP-1 Products

FDA is clarifying its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Texas that denied a preliminary injunction sought by the Outsourcing Facilities Association to allow continued compounding of the products.

Regarding tirzepatide (Lilly’s Zepbound and Mounjaro), the agency says that consistent with the recent ruling, enforcement discretion has ended for state-licensed pharmacy or physician compounding under Section 503A of the FD&C Act. For outsourcing facilities under section 503B, FDA does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list until 3/19.

Regarding semaglutide (Novo Nordisk’s Wegovy and Ozempic), FDA says state-licensed pharmacy or physician compounding can continue until 4/22 or until the date of a pending court decision involving a similar preliminary injunction motion sought by the  Outsourcing Facilities Association, whichever is later. For outsourcing facilities under Section 503B of the FD&C Act, they have until 5/22  or until the date of the court’s decision, whichever is later.

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