Skip Navigation
Print This Page
Share this page: More

FDA 312/812 Organization Policy on Clinical Investigations with FDA “Test Articles”

August 2010

The Organization authorizes the JHM IRB to review studies involving FDA regulated “test articles.”  Test articles may include drugs, botanicals, biologics, gene therapy, genetically derived products, and medical devices, as defined under FDA regulations on protection of human subjects (21 CFR 50 and 21 CFR 56), and the Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations (21 CFR 312 and 21 CFR 812). 




Traveling for care?

blue suitcase

Whether crossing the country or the globe, we make it easy to access world-class care at Johns Hopkins.

U.S. 1-410-464-6713 (toll free)
International +1-410-614-6424



© The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. All rights reserved.

Privacy Policy and Disclaimer