Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

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.
United States. Food and Drug Administration. Office of Global Regulatory Operations and Policy. Office of Regulatory Affairs, 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, July 2017
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Drug Industry -- standards
Drugs, Generic
Investigational New Drug Application
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 (15 pages)).
NLM Unique ID:
101713196 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101713196