us-fda-guidance-4e24df232b4e491220515c79f6999aa8•Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry
us-fda-guidance-4e24df232b4e491220515c79f6999aa8Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for IndustryGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
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.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
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