US FDA regulatory support

All federal agencies and departments in the US have their own rules and regulations for conducting human research, which must be adopted. If a new drug/device or an approved drug/device is to be administered for a new indication, then the test must be conducted in accordance with the US FDA rules and regulations.

The FDA conducts clinical research to ensure that it is designed, conducted, reviewed, and published in accordance with federal law and good clinical practice (GCP) requirements. The FDA sets the standard for clinical research and guidelines for the effective development of medicines, and provides credible evidence of their safety and efficacy.