The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as ...
Pharmaceutical regulatory consulting for drug developers and CROs: IND CMC, method validation, NDA strategy, and FDA ...
The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM approach.
Early 2026 has brought a series of consequential regulatory moves from the FDA, each reflecting a common thread: the agency ...
FDA draft guidance backs alternatives to animal testing in early drug development, outlining validation for new approach ...
Morning Overview on MSN
Effort to end animal testing grows, but alternatives still fall short
Federal regulators in the United States are pushing harder than ever to reduce and eventually replace animal testing in drug ...
MedPage Today on MSN
FDA proposes more flexibility in alternatives to animal testing in drug development
Non-animal testing methods could save drugmakers time and money, officials say ...
Please provide your email address to receive an email when new articles are posted on . The FDA announced plans in 2025 to reduce animal testing requirements in biomedical research. New approach ...
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