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- Title
Improving Carcinogenicity Assessment.
- Authors
Morton, Daniel; Bourcier, Todd; Alden, Carl L.
- Abstract
The ICH initiated talks in June 2012 to revise regulatory guidance for carcinogenicity assessment of pharmaceutical products, stimulated in part by a proposal called Negative for Endocrine, Genotoxicity, and Chronic Study Associated Histopathologic Risk Factors for Carcinogenicity in the Rat (NEGCARC) from the Pharmaceutical Research and Manufacturing Association (PhRMA). The 2012 STP Town Hall Meeting focused on the need for change in carcinogenicity assessment strategies for pharmaceuticals. Dr. Todd Bourcier from the Division of Endocrine and Metabolic Products, U.S. FDA and a member of the FDA’s Alternative Carcinogenicity Assessment Committee, was the guest speaker and a panelist. Dr. Bourcier is also one of FDA’s representatives to the ICH S1 Expert Working Group that is discussing changes to regulatory guidelines for carcinogenicity assessment. Drs. Carl Alden and Dan Morton also participated in the panel discussion.
- Subjects
CARCINOGENICITY testing; ENDOCRINE toxicology; GENETIC toxicology; PHARMACEUTICAL research; MEETINGS; BIOLOGICAL assay; HISTOPATHOLOGY
- Publication
Toxicologic Pathology, 2013, Vol 41, Issue 2, p263
- ISSN
0192-6233
- Publication type
Article
- DOI
10.1177/0192623312464310