FDA posted a table today with "an inventory of drug development contexts for which CDER is open to a streamlined nonclinical program" - that include the use of NAMs. It includes references to various guidance. A worthwhile reference for those interested in NAMs.
Replacing and Reducing Animal Testing at CDER
#fda #NAM
| U.S. Food and Drug Administration |
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| Replacing and Reducing Animal Testing at CDER |
| It has become increasingly clear that new approach methodologies (NAMs)-when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data-may offer ways to reduce animal testing. |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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