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 ...

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

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 ...

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 ...

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 ...

New approach methodologies (NAMs) are rapidly being adopted in the early stages of therapeutics development because they offer researchers more human-relevant models. NAMs encompass a wide range of ...

The FDA's shift towards an evidence-based approach in the coadministration of vaccines for respiratory viruses like COVID-19, flu, and RSV is stirring significant debate. Under the guidance of Vinay ...