All Knowledge & Insights By Date

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Applications (NURA) program is offering a free three-session training series on replacing the traditional two-year bioassay with a more effective, human-relevant carcinogenicity assessment. In “Tomorrow’s Data Today: Sunsetting the 2-year Carcinogenicity Assay,” toxicologists, risk assessors, and scientists will hear directly from other experts on the current progress among working...