The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. We are on a bureaucratic trajectory where American leadership in ...