Drugs

FDA Diversity Plan Draft Guidance Due: RAPS

The Regulatory Affairs Professionals Society (RAPS) says FDA is on schedule to publish a draft guidance on diversity plans before the end of this year. The society’s Regulatory Focus post says the guidance will take into consideration the unique challenges of conducting medical device clinical trials, citing an agency official at a recent conference.

The agency held several public meetings on the topic in recent years and published a 4/2022 draft guidance on the topic, RAPS says.

“Manufacturers are concerned that FDA may try to use the same approach for medical device applications as they would for drugs, even though medtech clinical trials are conducted very differently than those for drugs and biologics,” Johnson & Johnson director for evidence and outcomes policy Heather Colvin told the 2023 MedTech conference, RAPS reports. It says CDRH deputy director and chief transformation officer Michelle Tarver responded that the agency is being very careful about how it writes the guidance to prevent any undue burdens. “We are actively writing a section in the guidance that will apply to devices,” she said. “So yes, we are being thoughtful and intentional in thinking about that.”

Tarver also said FDA wants to be sure it encourages more diversity in clinical trials since it has found circumstances in which products don’t work as intended after patients have been enrolled in trials.

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