Drugs

FDA Launching Drug Risk Management Board

FDA says it is launching the Drug Risk Management Board, a “unified Center-level body that will ensure seamless alignment for marketed product safety activities among offices and will facilitate rapid analysis and resolution of drug safety issues.” An internal memo from CDER director Janet Woodcock says the board will coordinate major, complex, and high-impact safety issues by:

facilitating decision-making across the Center as it concerns major clinical and quality-related safety issues with marketed products;
providing clear and consistent guidance to generate an appropriate response to and communication about major safety issues; and
communicating recommendations, decisions, and actions to Woodcock and throughout the Center as appropriate.

The board also will continue the work of a Drug Risk Management Steering Committee appointed 6/2019 to facilitate and coordinate all marketed product safety issues across CDER and to provide strategic guidance on major safety issues.

Woodcock says the board includes CDER senior leadership as well as subject matter experts as needed. CDER deputy director for operations Patrizia Cavazzoni is the chair.

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