Drugs

Guidance on Generic Abuse-Deterrent Opioids

FDA has issued a draft guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, to assist potential applicants to develop and submit an ANDA for a generic version of a solid oral opioid drug product that has the potential for abuse and which references an opioid drug product with abuse-deterrent properties described in its labeling. An agency statement (includes link to guidance text) says that the document includes recommendations about studies, including comparative in vitro studies, that should be conducted to demonstrate that a generic opioid is no less abuse-deterrent than the innovator product across all potential routes of abuse, including mechanical manipulation, injection, ingestion, insufflation, and smoking.

A public meeting will be held later this year, FDA says, to discuss the draft guidance on generic abuse-deterrent formulation products and a broad range of issues related to using abuse-deterrent technology as one tool to reduce prescription opioid abuse. The agency says it will consider feedback from that meeting in finalizing the guidance.

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