Drugs

5th Annual Drug Safety Priorities Report Out

CDER director Janet Woodcock says the fifth annual drug safety priorities report issued by the Center “describes the scope and scale of the Center’s drug safety oversight programs, detailing the evolving and wide-ranging nature of our safety operations, with updates on several of the year’s milestones and achievements.” The report notes that the management of emerging drug safety issues has become more complex, requiring multidisciplinary collaborations across CDER.

“The work described in this report has continued to fuel the ongoing modernization and response capabilities of our safety surveillance and represents substantive contributions to protection of the public health,” Woodcock writes. “But with millions of drug products in the marketplace at all times, safety issues continue to arise with unprecedented frequency, demanding swift and comprehensive innovations in how we identify, assess, and address safety concerns.”

Topics covered in the report are safety surveillance and oversight of marketed drug products; nitrosamine impurities in medicines; continued efforts to address the misuse and abuse of opioid drugs; ensuring quality, safety, and effectiveness of generic drugs; safe use initiative; compounded drugs, and communicating drug safety.

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