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

WASHINGTON - The Food and Drug Administration released a draft guidance on Tuesday significantly reducing the range of ...

On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...

New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.

The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...

The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...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

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s ...

Last month, federal regulators released research guidance for classic psychedelics, marking the first time the government has offered suggestions for studying medicines like LSD, MDMA and psilocybin ...

The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a ...