FDA Commissioner Dr. Marty Makary reveals new guidelines for food packaging labels on products with natural dyes.
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual disease (MRD) and complete response (CR) as primary end points in clinical ...
FDA allows “no artificial colors” claims for natural dyes, but undefined “petroleum-based” categories leave manufacturers ...
In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.
WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...
WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...
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