Drugs

Stakeholder Diversity Action Plan Comments

The Society for Women’s Health Research says it recognizes the critical role of increasing diversity across the research enterprise by reducing barriers to clinical trial participation for underrepresented and marginalized populations and applauds FDA for its commitment to trial diversity as seen in a draft guidance on diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies. The society’s comment letter offers ideas for the agency’s consideration on these issues:

sex as a biological variable;
inclusion of diverse populations and intersectional identities;
inclusion of pregnant and lactating populations; and
best practices for recruiting diverse populations.

In its response, the International Society for CNS Clinical Trials and Methodology provides comments from 32 experts on considerations for the format and content of diversity action plans, considerations for multi-region clinical trials, and pharmacology considerations. The letter also has specific line-by-line comments.

The Friends of Cancer Research says it supports the draft’s objectives and submits comments on monitoring and reporting progress toward meeting enrollment goals; timing and types of FDA meetings to discuss diversity action plans; and public posting of key information.

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