Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

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 Medical Products and Tobacco. Oncology Center of Excellence, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (CDRH), issuing body.
Publication:
Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
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 (6 pages)).
NLM Unique ID:
101760537 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101760537