Drugs

Opioid Abuse Study Contracts Awarded

FDA has awarded contracts to two companies to help the agency better determine how to collect more scientifically valid data in postmarketing studies of opioid abuse deterrence in real-world evidence. An online conversation with CDER Office of Surveillance and Epidemiology associate director for public health initiatives Judy Staffa indicates that the contracts with the Denver Health and Hospitals Authority and Inflexxion, Inc., “will help us determine how to collect more scientifically valid data, as well as improve our interpretation of existing data.

Staffa says sponsors of abuse-deterrent opioids are in various stages of conducting required post-approval studies to evaluate whether their product actually decreases abuse and related adverse outcomes in the real world, outside of the controlled environment of pre-market testing. She says the sponsors face many challenges, in part because existing data sources have substantial limitations.

According to Staffa, participants at a July FDA workshop on the issue confirmed that the agency is tackling a complex and difficult problem that won’t be solved easily. “We will need to work together and think in different ways to address it,” she says. “We hope that innovative and creative collaborations addressing the opioid crisis will arise from some of these conversations, including ways to improve the design of studies and timely data collection to support these studies.”

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