FDA outlines plan to phase out animal testing in new draft guidance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The U.S. Food and Drug Administration issued a draft guidance on Wednesday to help drug developers validate alternative methods that can be used in place of animal studies during early stages of drug ...
JD Supra

FDA’s 2026 Guidance on General Wellness Devices: Policy for Low-Risk Devices

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...
Food Processing

FDA Reveals its 2026 Food Safety To-Do List

The agency’s lengthy “Human Foods Program 2026 Priority Deliverables” targets food dyes and other ingredients, the GRAS ...
Applied Clinical Trials Online

FDA Issues Draft Guidance to Validate Non-Animal Testing Methods in Drug Development

The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug development.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, ...
Fierce Pharma

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

FDA backs off stricter tanning bed rules with RFK Jr.'s support

Health officials with the Trump administration have backed away from an effort to more heavily regulate indoor tanning — despite protests from medical groups that warn of the dangers of skin cancer.
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FDA Updates Draft Guidance on Flavored Vapor Applications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 — The U.S. Food and Drug Administration (FDA) released draft guidance on how it intends to evaluate ...
Fierce Biotech

FDA, NIH pledge more flexibility and $150M investment for animal testing alternatives

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...
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 ...
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
PharmTech

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

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 ...