Addressing such fears, legal experts said the records will be sealed, not deleted or expunged, which in no way will condone ...
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FDA Draft Guidance Places New Limits on Toxicity Tests Involving Primates
WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...
The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...
The agency is proposing drugmakers use shorter nonrodent studies and other sources of evidence when developing monoclonal antibodies for non-cancer settings.
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New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.
Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead the agency's Center ...
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.
Rick Pazdur had clashed with Trump officials on the legality and pace of their initiatives. He could still withdraw his ...
The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...
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