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FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

FDA Issues Draft Guidance on Diversity Action Plans

On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more

Transforming Cosmetics Regulation: FDA’s Mandatory Compliance Shift for Safer Beauty

On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more

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