Drugs

New Guidance Promotes More Trial Diversity

FDA has published a new draft guidance, Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials, that expands on an earlier guidance intended to help the industry improve clinical trial diversity. The document says individuals from several named populations are frequently under-represented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

“Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations,” the guidance says.

An agency statement says the guidance recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.

The new draft expands on a 2016 guidance that outlined how to collect and present race and ethnicity data in submissions to FDA and recommended that sponsors develop and submit a plan to address the inclusion of clinically relevant populations for discussion with the agency. “Given the importance of increasing enrollment from historically under-represented racial and ethnic populations, FDA is publishing this guidance to provide detail on what sponsors should include in a Race and Ethnicity Diversity Plan,” it says.

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