FDA Releases Draft Bioequivalence ANDA Guides
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support ANDAs. To view the notice, click here.
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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