FDA

A vast majority of people still do not understand the process of drug development unless clinical trials are the only treatment option left, says Richard Torbett, chief executive at the Association of the British Pharmaceutical Industry (ABPI)....

New clinical treatments for diseases are conceived in a laboratory, then tested on animals or through simulations, and finally studied on human beings if deemed promising enough. Moving from point to point in this cycle is rarely a straight line, and costly and time-consuming trial-and-...

Commenters on the FDA's guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about decoupling drug administration from psychotherapy support, the proposed credentials for lead safety monitors and the agency’s characterization of the abuse potential of psychedelic drugs....