Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Collection:: Health Policy and Services Research
Series Title(s):: Guidance for industry
Contributor(s):: United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Language(s):: English
Format:: Text
Subject(s):: Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):: Guideline
Technical Report
Copyright:: The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:: 1 online resource (1 PDF file (24 pages)).
NLM Unique ID:: 101720078 (See catalog record)
Permanent Link:: http://resource.nlm.nih.gov/101720078