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The American Chemistry Council (ACC) appreciates the opportunity to provide written comments on the Food and Drug Administration’s (FDA) consideration of “Proposed change to rodent carcinogenicity testing of pharmaceuticals” - the International Conference on Harmonization (ICH) S1 guidance on rodent carcinogenicity testing. It’s our view that the FDA’s proposal to implement the requirement for submission of carcinogenicity assessment documents, in lieu of performing a two-year rat carcinogenicity study, is a sound approach that should be pursued.
Richard A. Becker, Ph.D. DABT
Attachments:
American Chemistry Council ACC Comments FDA Triggered CA Study 14 May 2013
Title: American Chemistry Council ACC Comments FDA Triggered CA Study 14 May 2013
American Chemistry Council (ACC) - Comment
This is comment on Notice
International Conference on Harmonisation: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals
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Attachments:
American Chemistry Council ACC Comments FDA Triggered CA Study 14 May 2013
Title:
American Chemistry Council ACC Comments FDA Triggered CA Study 14 May 2013
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