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
On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more
On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more
The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more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
The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which outlines the...more
On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the enrollment of historically...more
Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations...more
On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, “Diversity Plans to Improve Enrollment of...more