Biologics

Diversity Action Plan Submissions Up

An FDA summary report on clinical study diversity action plans for FY 2023 and FY 2024 shows that submission of the action plans to the agency is going up, even though such submissions are not yet required. The report shows that CDER received 124 plans in FY 2023 and 161 in FY 2024. The comparable figures for CBER were 9 and 21, and for CDRH they were 6 and 24.

The agency says it is working to finalize a 6/2024 draft guidance that will mandate the submission of diversity action plans for certain studies for which enrollment commences after 180 days from the publication of the final guidance.

Diversity action plans are to include the sponsor’s goals for enrollment in the clinical study, the sponsor’s rationale for such goals, and an explanation of how the sponsor intends to meet the goals, FDA says.

“Enhancing diversity within clinical studies not only facilitates applicability of results across a broad spectrum of patient populations but also enhances understanding of the disease or medical product under study,” the report concludes, “thus providing valuable insights to inform the safe and effective use of the medical product among patients.”

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

Read more

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