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COMPUTER FILE
Title PDUFA pilot project : proprietary name review.
Imprint [Rockville, MD] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [2008]

LOCATION CALL # STATUS MESSAGE
 ONLINE GOVERNMENT PUBLICATION  HE 20.4802:P 91    ONLINE  
Subject United States. Prescription Drug User Fee Act of 1992.
Business names -- Evaluation.
Alt Name Center for Biologics Evaluation and Research (U.S.)
Add Title Prescription Drug User Fee Act pilot project
Proprietary name review
LOCATION CALL # STATUS MESSAGE
 ONLINE GOVERNMENT PUBLICATION  HE 20.4802:P 91    ONLINE  
Subject United States. Prescription Drug User Fee Act of 1992.
Business names -- Evaluation.
Alt Name Center for Biologics Evaluation and Research (U.S.)
Add Title Prescription Drug User Fee Act pilot project
Proprietary name review
Description 38 pages : digital, PDF file
System Details Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/cder/guidance/8455%20FINALConcept%20Paper.pdf ; current access is available via PURL.
Note Title from PDF title page (viewed on Mar. 23, 2009).
"Concept paper."
"September 2008."
OCLC # 316878041