FDA Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
Title:
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/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072053.pdf
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.