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ElectronicResource GovDoc
Title
Reviewer guidance [electronic resource] : conducting a clinical safety review of a new product application and preparing a report on the review.
Imprint
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2005]
Connect to
Connect to https://permanent.fdlp.gov/LPS116705/fda/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072275.pdf
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Call No.
OPAC Message
Status
Axe Federal Documents Online
HE 20.4702:C 61/5
---
Available
Description
1 online resource (79 p.)
Note
"Good review practices."
"February 2005."
Subject
Clinical trials -- Reporting -- Government policy -- United States.
Drug approval -- Government policy -- United States.
Added Author
Center for Drug Evaluation and Research (U.S.)
Added Title
Conducting a clinical safety review of a new product application and preparing a report on the review
Gpo Item No.
0499-T (online)
Sudoc No.
HE 20.4702:C 61/5
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