Drugs

FDA Developing Peptide Evaluation Tools

FDA says it is developing scientific tools to facilitate evaluations of peptides and proposed generic equivalents. In an online Regulatory Science Impact Story, the agency discusses the scientific challenge for approval of generic peptide drug products and its research to support development and evaluation of peptide drug products.

“Different types of techniques are becoming available that can be used independently or in conjunction with each other to gather comprehensive information on impurities, amino acid sequences, and distributions of peptide properties,” the post says. “One powerful technique for analyzing peptides is mass spectrometry (MS). In MS, charges are added to the various molecules in a drug product and the molecules are then exposed to the forces of an electrical field. The subsequent motion of these molecules depends on the ratio of their charge to the mass, making it possible to identify the individual molecular species among hundreds of components in a sample.”

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