News & Analysis as of

Diversity and Inclusion Standards (D&I) Draft Guidance

DLA Piper

Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points

DLA Piper on

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

Foley & Lardner LLP

Decentralized Clinical Trials: Diversity in Clinical Trials

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) has demonstrated a commitment to expanding diversity in clinical trials. Decentralized Clinical Trials ( DCTs) contribute to this effort by enhancing convenience for trial...more

King & Spalding

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

King & Spalding on

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

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