The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
The agency’s lengthy “Human Foods Program 2026 Priority Deliverables” targets food dyes and other ingredients, the GRAS ...
The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy ...
The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance ...
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
Restricting teens’ access to indoor tanning and informing the public about the dangers of indoor tanning are critical to preventing skin cancer,’ AAD President Susan C. Taylor, MD, said.
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