Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

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.
Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Language(s):: English
Format:: Text
Subject(s):: Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):: 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 (i, 54 pages)).
NLM Unique ID:: 101767656 (See catalog record)
Permanent Link:: http://resource.nlm.nih.gov/101767656