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 ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...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 for Low Risk ...
The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...
The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug development. The guidance, ...
Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.
Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...
Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
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