Issue Date: February 1, 1987
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry
This guideline describes an acceptable format for organizing and presenting the pharmacology and toxicology data required under 21 CF 314.50(d)(2), and any related date, in the nonclinical section of the application. These recommendations pertain only to organization of existing data. This guideline is not intended to affect documentation required by the Good Laboratory Practices (GLP) reporting regulations under 21 CFR 58.185, nor does it describe the specific stufy requirements for particular therapeutic uses or regimens: these are addressed in other guidelines.
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