Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

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, December 2017
Language(s):: English
Format:: Text
Subject(s):: Communication
Drug Industry
Investigational New Drug Application
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 (ii, 34 pages)).
NLM Unique ID:: 101720046 (See catalog record)
Permanent Link:: http://resource.nlm.nih.gov/101720046