Drugs

Guidance Explains FDA 503B Wholesaling Ban

A long-awaited new FDA guidance explains how the agency interprets and intends to enforce the prohibition of wholesaling against facilities that compound drugs under Section 503B of the Federal Food, Drug, and Cosmetic Act. Six Reed Smith attorneys write in an online post that the guidance first describes FDA’s interpretation of some key words and phrases in the wholesaling prohibition.

It then gives examples of activities that the agency will generally consider to be prohibited by the law.

Third, the draft gives examples of activities that FDA generally will not consider prohibited under the law.

The attorneys say the agency is accepting comments on the draft guidance until 8/28. They say the draft “does provide significant insight into FDA’s thinking when it comes to the wholesaling prohibition and how the agency intends to approach regulatory or enforcement action against outsourcing facilities that run afoul of this statutory provision. Outsourcing facilities should closely monitor their compliance with the draft guidance as well as any future revisions made to the guidance as FDA enters the upcoming comment period.”

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