Drugs

FDA Draft Trial Diversity Guidance Outlined

Three Troutman Pepper attorneys say a 4/14 FDA draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, is the agency’s first attempt to articulate detailed expectations for submission of a plan by trial sponsors to ensure that clinical trial diversity goals are realized. The document recommends submitting diversity plans for products associated with an IND, IDE, NDA, BLA, PMA, 510(k), de novo classification, or HDE as soon as practicable and no later than when the sponsor is seeking feedback for applicable pivotal trials.

The attorneys list the five elements the agency is looking for in a diversity plan: (1) an overview of the disease or condition; (2) scope of the medical product development program; (3) goals for enrollment of underrepresented racial and ethnic participants; (4) a specific plan of action to enroll and retain diverse participants; and (5) status of meeting enrollment goals (as applicable).

“Although previous FDA guidance mentioned the need for a diversity plan,” the attorneys write, “sponsors now have a roadmap to ensure that their diversity plans contain the necessary elements to satisfy FDA and are submitted timely.”

They say it is likely the most difficult part of the diversity plan will be developing a strategy to ensure sufficient enrollment of under-represented populations. “An effective strategy should consider community outreach and burden reduction,” they say.

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