News & Analysis as of

Diversity Clinical Trials

Mintz - Health Care Viewpoints

FDA Issues Guidance Intended to Diversify and Enhance Clinical Trial Participation

On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

Foley & Lardner LLP on

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more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On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more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FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans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 FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA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On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented...more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

Goodwin

FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Goodwin on

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....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

Holland & Knight LLP

Holland & Knight Health Dose: May 21, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....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

[Webinar] Achieving Diversity in Clinical Trials: Expanding the Role of Community Hospitals - November 2nd, 1:00 pm - 2:00 pm ET

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

Foley & Lardner LLP

Decentralized Clinical Trials Blog Series: Introduction

Foley & Lardner LLP on

Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...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

Stevens & Lee

FDA Working to Encourage Diversity and Equity in Clinical Trials

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The FDA has recently made efforts to encourage more diversity and equity in clinical trials by releasing “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

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