News & Analysis as of

Diversity Life Sciences Clinical Trials

McDermott Will & Emery

FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

McDermott Will & Emery on

On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

Foley Hoag LLP

Action Plans on Diversity: Key Requirements for Certain Clinical Studies

Foley Hoag LLP on

On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more

Epstein Becker & Green

FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

Epstein Becker & Green on

The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

King & Spalding

Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

King & Spalding on

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more

BakerHostetler

FDA Issues Draft Guidance on Diversity Action Plans

BakerHostetler on

On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more

Bass, Berry & Sims PLC

FDA's Diversity Action Plans for Clinical Trials: Key Deadlines and Compliance Requirements

The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Hogan Lovells

FDA publishes long-awaited clinical trial diversity guidance

Hogan Lovells on

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

Manatt, Phelps & Phillips, LLP

Achieving a High Performance, Diverse Accrual, Clinical Trial Program in an Academic Health System

The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques. At the nexus of these advances are clinical...more

Hogan Lovells

FDA clinical trial diversity workshop reveals agency’s expectations for sponsors

Hogan Lovells on

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

Manatt, Phelps & Phillips, LLP

Achieving Diversity in Clinical Trials - Expanding Hospital Capacity to Offer Clinical Trials in the Community

Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more

Hogan Lovells

Clinical trial diversity data can be boosted post-approval, FDA guidance explains

Hogan Lovells on

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

Goodwin

Clinical Trial Diversity Plans and Rare Diseases

Goodwin on

Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] Achieving Clinical Trial Diversity: An Overview of the Policy Landscape and Ongoing Challenges - October 12th,...

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - Although increasing representation of underserved populations in clinical trials has...more

American Conference Institute (ACI)

[Event] Women Leaders in Life Sciences Law Summit - July 27th - 28th, Boston, MA

ACI’s Flagship Summit for Women Leaders in Life Sciences Law is returning LIVE and IN-PERSON to Boston this July! This summer’s reunion event will provide the renewed opportunities for in-person networking and...more

Hogan Lovells

FDA issues ambitious new draft guidance to promote clinical trial diversity

Hogan Lovells on

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

MoFo Life Sciences

FDA’S Loud And Clear Message: Engage With FDA Early And Formally

MoFo Life Sciences on

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more

Hogan Lovells

A step in the right direction: Encouraging diversity in clinical trial populations

Hogan Lovells on

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs. ...more

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