Drugs

Updated CDER Guidance Agenda

CDER has posted a revised guidance agenda for calendar year 2024. The agenda lists 101 new, revised draft, and immediately effective guidances in these 17 categories: Administrative/Procedural (11), Biosimilars (4), Clinical/Antimicrobial (1), Clinical/Medical (20), Clinical Pharmacology (1), Compounding (7), Drug Development Tools (1), Drug Safety (3), Generics (21), International Council on Harmonization (10), Labeling (3), Over-the-Counter Drugs (2), Pharmaceutical Quality CGMP (3), Pharmaceutical Quality/CMC (10), Pharmacology Toxicology (2), Promotional Labeling and Advertising (1), Real-World Data/Real-World Evidence (3).

The document lists 12 guidances that were added since the January posting of the initial guidance agenda.

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