Drugs

Guide on Race/Ethnicity Data Reporting

FDA has posted a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The document outlines FDA’s recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions, including information collected and reported from clinical trials and clinical studies for regulated medical products. The recommended approach is based on the Office of Management and Budget’s (OMB) Statistical Policy Directive No. 15, the guidance says.

FDA’s draft guidance provides recommendations on:

Meeting the requirements under the agency’s 1998 final rule about presentation of demographic data in INDs/NDAs.
Race and ethnicity data collection in BLAs and medical device applications.
Addressing the FDA Safety and Innovation Act Section 907 Action Plan to improve the completeness and quality of demographic data collection and reporting

The agency notes that the 1998 rule also requires the sponsor of an IND to tabulate in an IND annual report the number of participants enrolled in the clinical trial by certain demographic subgroups (including race) and requires NDA submissions to include summaries of effectiveness and safety data for demographic subgroups (including racial subgroups).

Additionally, the draft guidance says FDA’s regulations require that medical product sponsors submit a diversity action plan outlining (1) the sponsor’s goals for enrollment in the clinical trial, (2) the sponsor’s rationale for such goals, and (3) an explanation of how the sponsor intends to meet such goals.

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