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The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program has announced two upcoming webinars in the DyNAMic Discussions series. This webinar series invites speakers to share candid perspectives on how they have overcome barriers to apply NAMs in their fields and discuss how these examples can be used to promote the use of NAMs in other situations. All DyNAMic Discussion webinars have been recorded. Materials,...

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...

At its June 22, 2007, meeting, the National Toxicology Program’s (NTP) Board of Scientific Counselors (BSC) reviewed nominations of several substances for testing, including nanoscale silver. The Food and Drug Administration nominated nanoscale silver for toxicological studies “based on (a) increasing widespread use in drug, food and cosmetic products, and (b) the general lack of data on the toxicology and pharmacokinetics of these materials.” Comments on the...