Drugs

GDUFA Regulatory Science Priorities

Under terms of the Generic Drug User Fee Amendments of 2012, FDA is to prepare a yearly list of regulatory science priorities for generic drugs based on input from industry and other stakeholders. The agency has released this list of priorities for FY 2017:

post-market evaluation of generic drugs, including research into monitoring methods, understanding patient perceptions of generic drug quality and effectiveness, and verifying therapeutic effectiveness through brand-to-generic switching studies;
equivalence of complex drug products, including research into making generic versions available in all product categories, including complex drugs with unique characteristics;
equivalence of locally-acting products, including research into new bioequivalence methods and pathways for locally-acting drugs;
therapeutic equivalence evaluation and standards to support the evolution of risk-based equivalence and product quality standards to ensure therapeutic equivalence across all dosage forms and delivery routes; and
computational and analytical tools including physiologically-based pharmacokinetic or absorption models, pharmacodynamic or clinical trial simulation, systems biology, and quantitative risk modeling.

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