In the US, the FDA, and elsewhere other regulatory agencies ensure that foods, cosmetics, drugs, medical devices and radiation emitting products are safe and effective. These agencies oversee regulations of drugs and medical devices, with respect to both clinical development and marketing of such products. The regulations also ensure that clinical studies on these products are conducted in such a way that subject’s welfare is guarded. Innovators are required to complete preclinical studies and incorporate them in the investigational new drug application (IND) that is required to be approved before clinical trials can be initiated.

Investigational New Drug Development

Also checkout: Full Clinical Research Notes – Pharm.D Notes for Other Subjects