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University of Colorado Denver

 

LINKS

Office of Regulatory Compliance


Investigator Responsibilities and Information
 
 
"Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Information Sheet Guidance for Institutional Review Boards and Clinical Investigators
 
Educational Materials Useful References
 
INDs
Guidance for Industry Investigational New Drug Applications (INDs) Determining Whether Human Research Studies Can Be Conducted Without an IND

 
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers
Institutional Review Boards Frequently Asked Questions - Information Sheet Information Sheet - Guidance for Institutional Review Boards and Clinical Investigators
 
 

 
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