The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...

The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...

On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...

The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...

WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the ...

Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of ...

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...

The FDA has proposed industry guidance to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal ...