Drugs

FDA Issues 2 Drug Compounding Guidances

FDA has issued two guidances on human drug compounding. The first, Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities, has been issued in final form to describe the conditions under which FDA does not intend to take action for certain violations of the Federal Food, Drug, and Cosmetic Act when state-licensed pharmacy, federal facility, or outsourcing facility repackages certain drug products. The document explains that the agency regards repackaging as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container, without further manipulation.

The second guidance, Mixing, Diluting, and Repackaging Biological Products Outside the Scope of an Approved Biologics License Application, is a revised draft that describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. The document replaces an earlier draft. Changes in the revision include longer beyond-use-dates and a mechanism for outsourcing facilities to assign such dates for repackaged biological products based on data.

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