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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Guidance for Industry
Submission of Abbreviated Reports and
Synopses in Support of
Marketing Applications |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072053.pdf |
| 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/ |
| 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. |
| Document Type: | Guidance for Industry |
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