Drugs

8 GDUFA Science and Research Priorities

FDA has released a list of eight priority areas for the GDUFA science and research program in FY 2025. “These eight areas encompass scientific challenges that the generic industry and FDA’s generic drug program identify as being significant over the coming years, and they also represent opportunities for scientific advances to accelerate access to generic versions of complex products and make the development of generic drugs more efficient and globally harmonized,” FDA says in a statement.

FY 2025 priorities were identified for each of these eight broad areas: develop methods for generics to address impurities such as nitrosamines, enhance the efficiency of equivalence approaches for complex active ingredients, enhance the efficiency of bioequivalence (BE) approaches for complex dosage forms and formulations, enhance the efficiency of BE approaches for complex routes of delivery, enhance the efficiency of equivalence approaches for complex drug-device combination products, improve the efficiency of BE approaches for oral and parenteral generic products, facilitate the utility of model-integrated evidence to support demonstrations of BE, and expand the use of artificial intelligence and machine learning tools.

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