2. The draft Post-market Assessment Prioritization Tool currently includes four Public Health criteria and three Other Decisional criteria. a. Are the four Public Health criteria appropriate for the ...

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 ...

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 ...

Real change takes a long time, and when it happens, it must be recognized. The FDA and the NIH have announced their move away from animal testing, improving scientific outcomes and marking a victory ...

Drug discovery requires experimental systems that more accurately capture the complexity of human tissues. However, animal models and conventional cell culture approaches often lack the physiological ...

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 ...

Motivated by the latest drug development regulatory guidance, such as the US Food and Drug Administration Modernization Act 2.0, academic and biopharmaceutical industry professionals are increasingly ...