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USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products".


As part of this guidance, FDA expects, and recommends, the use of a standardized method for collecting and reporting race and ethnicity data in submissions of clinical studies and clinical trials for FDA-regulated medical products, including information from clinical studies and clinical trials.


This guidance is also intended to help an applicant prepare a BLA or a device premarket submission, which should be done by the Office of Management and Budget (OMB) standards regarding the collection and reporting of race and ethnicity data described herein.


This guidance provides recommendations on:

  1. Meeting the requirements outlined in the 1998 final rule regarding the presentation of demographic data in investigational new drug applications (INDs) and new drug applications (NDAs) (known as the Demographic Rule)

  2. Collection of race and ethnicity data in biologics license applications (BLAs) and medical device applications

  3. Addressing the FDASIA Section 907 Action Plan to improve the completeness and quality of demographic data collection and reporting


The guidance is open and anyone can submit either electronic or written comments on the draft guidance by April 29, 2024. Click this LINK to know more about this guidance in detail.

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