The US Food and Drug Administration, neurologists, and drug development and regulation

Summary The US Food and Drug Administration (FDA) plays a vital role in the regulation of human drugs and therapeutic biologics. Most physicians, while aware of the broad reach of the FDA, are unaware of what the agency actually does and how it does it. Practicing neurologists should be aware of the role neurologists can play in drug development, the informational resources that the FDA provides to practitioners, and the process of submitting reports of suspected adverse drug reactions to the FDA.