Medical Device Legal News with Sam Bernstein: Episode 11
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more