The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
Pharmaceutical Technology on MSN
FDA steps back from preclinical primate testing amid wider regulatory shift
New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.
The Well News on MSN
FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates
WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...
The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
Scholars argue that federal drug agency actions should take precedence over conflicting state regulations. How should courts handle state regulations that restrict access to pharmaceuticals previously ...
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