Drugs

Temple Adds New Drugs Senior Advisor Hat to Responsibilities

CDER deputy Center director for clinical science Bob Temple is being appointed to a new position at the Center — Office of New Drugs senior advisor. Temple has for many years worn simultaneous hats within CDER and his new role is being added to his deputy Center director responsibilities; he, however, is dropping his long-held position as acting deputy director of the Office of Drug Evaluation I.

As OND senior advisor, Temple will serve as a consultant to newly appointed OND director Peter Stein and other FDA officials on matters related to clinical program objectives. “Based upon his broad and extensive experience, and his deep knowledge of regulatory policy and precedent, Bob will provide the OND director and senior leadership with advice on medical decisions that are controversial, complex, or critical in nature,” says CDER director Janet Woodcock. “He will also provide advice on a wide range of policy and programmatic matters, such as those related to study design and endpoints, determinations of the adequacy of evidence of effectiveness and safety, and the assessment of study results and labeling implications, among others. Bob will serve as a deciding official for OND-level appeals. He will have delegated authority to sign off on new drug applications.”

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