Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM approach.
The FDA has released draft guidance aimed at helping drug developers shift away from traditional animal testing as the ...
Non-animal testing methods could save drugmakers time and money, officials say ...
FDA draft guidance backs alternatives to animal testing in early drug development, outlining validation for new approach ...
Sponsors will now be able to submit preclinical toxicology data using virtual animal controls instead of a standard animal ...
As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...