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Section 6: FDA Regulated Research/Drugs & Devices
6.1 Research Involving Investigational and Marketed Drugs
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.2 Research Involving Investigational and Marketed Devices
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.3 Humanitarian Use Device (HUD)
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.4 Emergency Use of a Test Article
1.0 Purpose The purpose of this policy and procedure is to describe the requirements for utiliza...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for ut...