Drugs

FDA Challenges in Implementing Compounding Law: GAO

The Government Accountability Office (GAO) says that FDA has taken steps to implement its regulatory responsibilities to oversee drug compounding, but states and stakeholder organizations have said there are some challenges. A GAO report says FDA has issued numerous draft and final guidances related to drug compounding and has conducted more than 300 inspections of drug compounders, resulting in actions such as Warning Letters and voluntary recalls of potentially contaminated compounded drugs.

“Some stakeholder organizations said the amount of time it takes FDA to finalize the guidance and other documents, including those required by the 2013 law, is challenging,” GAO says. “FDA officials noted that reviewing the large number of comments received has contributed to the time the agency has taken to finalize them. States and stakeholder organizations also cited concerns related to access to compounded drugs and differences between states and FDA on the appropriate inspection protocols to use when inspecting drug compounders. In August, FDA changed its procedures to address concerns about the appropriate protocols to use for these inspections.”

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