Submission of Abbreviated Reports and Synopses in Support of Marketing Applications.
This document provides guidance to applicants on submitting abbreviated reports and synopses in lieu of full reports for certain clinical studies, both in marketing applications for new drug and biological products and in supplements to approved applications. This guidance is intended to meet the requirements of Section 118 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), which directs FDA to issue guidance on when abbreviated study reports may be submitted in new drug applications (NDAs) and biologics license applications (BLAs) in lieu of full 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.