BioSpace

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...

FDA outlines plan to phase out animal testing in new draft guidance

The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...

FDA issues guidance on alternatives to animal testing

The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
Applied Clinical Trials Online

Four FDA Actions Reshaping Drug Development in 2026

Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
CSNews

FDA Updates Draft Guidance on Flavored Vapor Applications

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...
PharmTech

What FDA's NAM Guidance Means for Pharmaceutical Development

FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...

2026 FDA Guidance: What Dietary Supplement Brands Need to Know

Comprehensive 2026 guide details DSHEA, 21 CFR Part 111 GMPs, NDI notifications, labeling, and FDA enforcement trends ...