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GUIDANCE DOCUMENT

Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. September 1999

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1998-D-0141
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-1998-D-0141.

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