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 initi...

CNS researchers have implemented surveillance strategies from within pharmaceutical companies, through contract research organizations, or by using one of the many in...

On June 26, 2013, the US Food and Drug Administration (FDA) announced in the Federal Register, the publication of a draft guidance for industry entitled “Expedited Pr...