Phasing out animal testing in preclinical drug trials in favor of unvalidated alternate methodologies could ultimately backfire and raise safety and effectiveness concerns, says Sara Gerke, the ...

Following its release of a roadmap for phasing out animal testing, on March 18, 2026 FDA released a draft guidance on General Considerations for the Use of New Approach Methodologies in Drug ...

On February 23, 2026, the US Food and Drug Administration (FDA) released draft guidance outlining a new “plausible mechanism framework” that offers sponsors of certain individualized rare disease ...

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

New guidance suggested by Dr. Vinay Prasad, in a paper published on Tuesday, argues for increased testing of seasonal COVID-19 shots. The FDA says the new approach will aim to balance a timely ...

In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can ...

The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only ...

WASHINGTON, March 19, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), a leader in innovative drug development and a vocal advocate for reducing unnecessary animal testing, ...

Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research Collaborations Extended projects support ongoing research into computational approaches and new approach methodologies for food and ...