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GUIDANCE DOCUMENT

1988 FDA Guidance for the Format and Content of the Clinical and Statistical Section of an Application April 2019

Final

1988 FDA Guidance for the Format and Content of the Clinical and Statistical Section of an Application

Issued by:
Guidance Issuing Office
Office of the Commissioner

Not a guidance - expiring


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:

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.