Drugs

GDUFA Research Helped Product-Specific Guidances: Report

In an FY 2025 GDUFA Science and Research Report, GDUFA Science and Research Program joint directors Iilun Murphy and Michael Kopcha say extended GDUFA-funded research on bioequivalence (BE) risk assessments and Biopharmaceutics Classification System classification supported the FY 2025 publication of over 800 product-specific guidances that aligned FDA’s BE recommendations with newly adopted International Council on Harmonization standards for immediate-release solid oral dosage forms. In addition, the two say, GDUFA research allowed FDA to evaluate whether proposed BE approaches in pre-ANDA product development meetings are likely to be suitable.

Agency approval of the first generic liraglutide injection (referencing Novo Nordisk’s Victoza) and approval of additional generic liraglutide injections and the first generic liraglutide injection referencing Novo Nordisk’s Saxenda were facilitated by GDUFA research focused on developing analytical and in silico approaches to accurately characterize the molecular structure and impurity profiles of peptide drugs such as them, the report says.

The report describes active research projects and outcomes in the eight priority research areas for FY 2025 — impurities, complex active pharmaceutical ingredients, complex dosage forms and formulations, complex routes of delivery, drug/device combination products, oral products, quantitative methods and models, and data analytics and artificial intelligence — and other generic drug research.

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