New FDA Rules Require More Minorities in Clinical Trials


Published: April 17, 2022

The FDA will now require companies to file a “race and ethnic diversity plan” with the agency when working on clinical development for treatments. The new regulations for pharmaceutical and medical device companies will increase the number of Black individuals as well as other underrepresented minorities in their clinical trials. People from disadvantaged populations and diverse backgrounds are often left out because of factors like religious affiliation, illiteracy, a lack of knowledge about clinical trials, and a suspicion of medical professionals. The FDA’s Office of Minority Health and Health Equity will help companies to meet the new guidelines. 

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