The FDA’s emerging framework represents more than a regulatory update; it is a paradigm shift toward human-relevant, ...
Although new approach methodologies (NAMs) are not that new, they remain a crucial and evolving aspect of the development and production of biopharmaceuticals. “NAMs have been around for 20 years plus ...
The FDA has said it intends to reduce or replace animal testing of some medicines, including monoclonal antibodies, with other methods that it hopes will be more relevant to human physiology. Among ...
April was a remarkable month for both the scientific and regulatory communities in clinical research. The FDA finally set concrete plans for implementing the FDA Modernization Act 2.0, bringing us ...
EMA encourages NAMs to replace animal testing, aligning with 3Rs principles, and has published a concept paper on regulatory acceptance. EFPIA supports phasing out animal testing, emphasizing ...
New approach methodologies (NAMs) aim to streamline early-stage drug discovery and revolutionize preclinical testing by replacing traditional animal-based models with human-relevant insights, directly ...
DiNABIOS celebrates U.S. Senate passage of FDA Modernization Act 3.0, promoting human-relevant NAMs for drug development and reducing animal testing ...
AUSTIN, Texas, April 11, 2025--(BUSINESS WIRE)--ImmunoPrecise Antibodies Ltd. (IPA) (NASDAQ: IPA) a leader in AI-driven biotherapeutics, today announced its strong support for the U.S. Food and Drug ...
DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human-Relevant New Approach Methodologies (NAMs) DiNABIOS Applauds Historic U.S. Senate Passage of FDA ...
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