Drugs

Woodcock Outlines Drug Safety Efforts

In an FDA Voices online report, CDER director Janet Woodcock describes many of the agency’s activities to ensure that drugs it approves are not only effective, but safe. “Safety is a priority both before and after approval, and maintaining the safety of drugs that Americans rely on is a complex undertaking because new safety issues can arise at any time — regardless of how long a drug has been in use or its past record of safety,” she writes.

Much of the report is devoted to reviewing the agency’s actions when it learned of an unexpected impurity in a manufacturer’s version of the generic drug valsartan. Woodcock says the agency’s response illustrates several aspects of its approach to managing drug safety concerns, including transparency and rapid public communications. She says there is also behind-the-scenes work integral to the ability to understand and respond when drug safety concerns arise, including that of FDA laboratory scientists who investigate the precise chemical nature of drug safety questions.

The article also discusses CDER’s special emphasis on generic drugs and compounded drugs, and its efforts as part of the broader work to combat the nation’s opioid crisis.

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