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 ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

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 ...

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 ...

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 ...

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 ...

Sanford Burnham Prebys is one of several institutions contributing to the federally funded project called PREDICTS ...