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Food and Drug Administration (FDA) › Department of Health and Human Services (HHS) › Diversity

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Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans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On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more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

Proskauer - Health Care Law Brief on

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

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials.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

King & Spalding

White House’s FY 2023 Budget Request Includes Healthcare Provisions

King & Spalding on

President Biden submitted his Fiscal Year (FY) 2023 budget request to Congress on March 28, 2022. The budget request is not binding on Congress. Rather, it may serve as a guide for both Congress and the administration as they...more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

Bass, Berry & Sims PLC on

The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

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