Carcinogenicity Study Protocol Submissions

Issue Date: May 23, 2002
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final

Carcinogenicity Study Protocol Submissions

This guidance is intended to inform sponsors of the types of information the Center for Drug Evaluation and Research (CDER) relies on when evaluating protocols for animal carcinogenicity studies.

Download the Guidance Document

webmaster2026-08-05T19:00:37+00:00

ABOUT US

Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.