Drugs

Change Biological Drug Monographs: Petition

The University of Illinois Chicago College of Pharmacy is petitioning FDA to revoke the agency order stopping the U.S. Pharmacopeia (USP) from creating modified monographs of biological drugs. The petition says FDA could reduce the cost of developing biosimilars without compromising their safety and efficacy by removing the side-by-side testing for analytical comparison with the reference product.

The petition says USP and other pharmacopeias have been active in resolving quality issues by providing product monographs that include specifications and test methods. It says FDA has halted this model for biological drugs. “The FDA concerns can be removed by creating a novel monograph that deals with the release specification of a biological product, which will eliminate the need for side-by-side testing of a biosimilar candidate with its reference product,” the university says.

The petition notes that for such a proposal to succeed, USP will need additional ongoing funding. It recommends that funds come from associations supporting biosimilars and from federal agencies, including FDA.

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