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FDA Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry
Content:
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.

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