Drugs

FDA Schedules an Opioid REMS Workshop

FDA will hold an online virtual public workshop entitled “Evaluating the Effect of the Opioid Analgesic Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes — Exploring the Path Forward for Assessment.” A Federal Register notice says the workshop will be held on 12/11. Three major topics for discussion during the workshop are:

specific, measurable outcomes that might demonstrate that the REMS training based on the FDA Blueprint is effective in educating prescribers and other healthcare providers involved in the treatment and monitoring of patients in pain about recommended pain management practices and the appropriate use of opioid analgesics;
the feasibility of conducting a study to specifically evaluate the effects of opioid analgesic REMS-compliant continuing education on prescriber behavior and patient outcomes amidst the numerous concomitant strategies to combat the opioid crisis at the federal, state, and local levels; and
whether there might be suitable alternative study approaches to better understand the influence of continuing education, more broadly, on pain management practices and patient outcomes, if a study to directly measure the impact of REMS-compliant continuing education is thought to be infeasible.

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