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The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...
Pharmaceutical Technology on MSN
FDA steps back from preclinical primate testing amid wider regulatory shift
New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.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FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates
WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
Schrodinger, Inc.'s current valuation is more than justified by its software business. Click here to read why SDGR stock is a ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
The FDA has proposed industry guidance to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal ...
As President Donald Trump’s administration weighs changes to vaccine access in the U.S., Illinois Gov. J.B. Pritzker signed a ...
The World Health Organization issued new guidelines recommending the use of GLP-1 drugs for adults with obesity and called for action on manufacturing and affordability.
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