Current Edition


Specifying Therapeutic Area Standards for Clinical Research.

In its efforts to facilitate clinical research and regulatory review of drugs and biologics, the US Food and Drug Administration (FDA) has launched a multi-year initiative to standardize key study data to therapeutic areas (TAs). Guiding the project is the Therapeutic Area Standards Initiative Project Plan, to provide the overall management framework for addressing and accomplishing the objectives of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Deborah A. Komlos of Thomson Reuters explains the new standards.