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Guidance for industry : information request and discipline review letters under the prescription drug user fee act.

Bibliographic Details
Corporate Authors: Center for Biologics Evaluation and Research (U.S.), Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research, [2001]
Subjects:
Pharmaceutical policy > United States.
Drug control > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS113169
Description
Item Description:Title from PDF title page (viewed on May 28, 2009).
"November 2001".
Electronic resource.
Physical Description:5 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/pdufa-irdr.pdf ; current access is available via PURL.