Format and Content of the Clinical and Statistical Sections of an Application
This guideline is intended to assist an applicant in presenting the clinical and statistical data required as part of an application under 21 CFR 314.50. The guideline describes an acceptable format for organizing the clinical and statistical sections and presenting the clinical and statistical information and accompanying statistical documentation of a clinical trial. With respect to documenting the results of individual studies, the guideline describes a fully integrated clinical and statistical report rather than two separate reports.
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.