Drugs

30 New Product-Specific Guidances Out

FDA has published 30 new product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The agency PSG Web page has links to the lists of 21 new and nine revised PSGs.

There are 21 PSGs for products with no approved ANDAs, including 13 complex products, FDA says. Some 19 of the entries are for complex products (14 new and five revised PSGs).

The notice says noteworthy PSGs in the latest batch are dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

When finalized, FDA says, the guidances in this batch posting will describe its current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.

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