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Title
Guidance for industry [electronic resource] : submitting type V drug master files to the Center for Biologics Evaluation and Research.
Imprint
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001]
Connect to
Connect to http://purl.access.gpo.gov/GPO/LPS113193
Copies
Location
Call No.
OPAC Message
Status
Axe Federal Documents Online
HE 20.4802:D 84/2
---
Available
Description
i, 5 p. : digital, PDF file
System Details
Mode of access via the FDA CBER web site.
Note
Title from PDF title page (viewed on May 28, 2009).
"Draft guidance".
"August 2001".
Includes bibliographical references (p. 5).
Subject
Drug factories -- Government policy -- United States.
Filing systems -- United States.
Biologicals -- Government policy -- United States.
Added Author
Center for Biologics Evaluation and Research (U.S.)
Added Title
Submitting type V drug master files to the Center for Biologics Evaluation and Research
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:D 84/2
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