Drugs

Guidance on Study Underrepresentation Diversity Plans

FDA has published a draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist sponsors conducting certain clinical studies involving drugs, biological products, and medical devices to meet the requirements for the submission of diversity action plans under the Federal Food, Drug, and Cosmetic Act. The document says the plans are intended to increase the enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population.

The agency says it is issuing the draft to meet a requirement in the Food and Drug Omnibus Reform Act of 2022 that requires an update or guidance relating to the format and content of diversity action plans. The guidance describes the format and content of the plans, including the timing and process for submitting such plans by application or notification type. The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, also known as a waiver.

The draft includes an Introduction; Background; Clinical Studies Requiring Diversity Action Plans; Addressing Race, Ethnicity, Sex, and Age Group in Diversity Action Plans; Content of the Diversity Action Plan; Timelines for Submitting Diversity Action Plans; Procedures for Submitting the Diversity Action Plan and Receiving Feedback; Requesting Diversity Action Plan Waivers; Sponsor Public Posting of Key Information from Diversity Action Plans; and an Appendix.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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