ANDA submissions--amendments to abbreviated new drug applications under GDUFA

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 Drug Evaluation and Research (U.S.), issuing body.
Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Language(s):: English
Format:: Text
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
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 (26 pages)).
NLM Unique ID:: 101734373 (See catalog record)
Permanent Link:: http://resource.nlm.nih.gov/101734373