The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
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FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates
WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...
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New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
Dec 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab ...
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...
The Food and Drug Administration (FDA) is set to implement stricter vaccine approval guidelines after a memo claimed at least ...
It’s getting out of control. It’s distorting the doctor-patient relationship, these endless pharmaceutical ads,” Makary told ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
The FDA is offering staff a broad set of agentic AI tools despite concerns that the technology can behave unpredictably ...
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