New draft guidance from the U.S. Food and Drug Administration (FDA) facilitates enrolling more participants from underrepresented racial and ethnic U.S. populations into industry clinical trials. According to FDA, despite their disproportionate burden for certain...
Jacob Simpson
, Breazeale Sachse & Wilson LLP
The U.S. Food and Drug Administration (FDA) recently published draft guidance encouraging sponsors of medical products to include...
The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” (Guidance). The purpose of the...
FDA recommends the submission of a Plan for all medical products for which an IND submission is required or for which clinical studies are intended to support a marketing submission under section 351(a) of the PHSA, or under 505(b)(1) or 505(b)(2) of the Federal Food,...
Individuals who participate in randomized clinical trials should be representative of the patients who will be treated with the drugs under investigation. “Unfortunately, studies have consistently shown that women and those from racial and ethnic minority groups are...
