Drugs

FDA Holding Public Meeting on Opioid Abuse Deterrence

FDA commissioner Scott Gottlieb says that as part of his initiative to identify more steps his agency can take to address opioid addiction, FDA will hold a 7/10-11 public meeting focusing on the question of whether the agency has the right information to determine whether opioid medications with abuse-deterrent properties are having their intended impact on limiting abuse and helping to curb the epidemic. At the meeting, he says in a statement, FDA will “engage external thought leaders in a discussion about how we can better leverage existing data sources and methods to evaluate the impact of these products in the real world, as well as what new data sources and study designs could be developed or enhanced to ensure these efforts result in the best possible answers to inform regulatory decision-making.”

To help inform the discussion, Gottlieb says, the agency has released an issues paper outlining some of the existing regulatory and public health challenges it faces. While abuse-deterrent opioids may hold promise as one part of a broad effort to reduce the rates of misuse and abuse, Gottlieb concludes, “we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations….”

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