Drugs

Drug, Biologicals Benefit/Risk Assessment Guidance

FDA has published a draft guidance, Benefit-Risk Assessment for New Drug and Biological Products, to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that FDA makes about NDAs and BLAs. The document gives important considerations that factor into CDER and CBER benefit/risk assessments, including how patient experience data can be used to inform the benefit/risk assessment.

It then discusses how sponsors can inform the agency’s benefit/risk assessment through the design and conduct of a development program, as well as how they may present benefit and risk information in a marketing application. And it discusses opportunities for interaction between FDA and sponsors to discuss benefit/risk considerations in connection with the development of an NDA or BLA.

The guidance contains Introduction, FDA’s Approach to the Benefit/Risk Assessment of New Drugs and Biologics, Important Considerations for FDA’s Premarket Benefit/Risk Assessment of Drugs and Biologics, Activities That Occur in Premarket Development That Inform Benefit/Risk Assessment, and Benefit/Risk Assessment Conducted in the Postmarket.

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