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Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.

Bibliographic Details
Corporate Author: Center for Biologics 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, [2001]
Subjects:
Drug factories > Government policy > United States.
Filing systems > United States.
Biologicals > Government policy > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS113193
Description
Item Description:Title from PDF title page (viewed on May 28, 2009).
"Draft guidance".
"August 2001".
Includes bibliographical references (page 5).
Electronic resource.
Physical Description:i, 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/dmfv.pdf ; current access is available via PURL.