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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.