ABSTRACT
The US Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA, 2012) introduced the Breakthrough Therapy Designation (BTD), a new tool to expedite development of medicines to treat serious or life-threatening diseases. The majority of BTDs have gone to oncology drugs, and a recent publication by Shea et al.1 reviewed the impact of BTD on oncology drug development. This article reviews the impact of BTD on development strategies and timelines for nononcology drugs.
Subject(s)
Drug Approval/legislation & jurisprudence , Drug Design , Pharmaceutical Preparations/administration & dosage , Vaccines/administration & dosage , Humans , Time Factors , United States , United States Food and Drug AdministrationABSTRACT
Previous publications have focused on drug lag in Japan and the government's initiatives to address the situation.(1) Japan is the third largest pharmaceutical market, and yet has experienced significant drug lag for many years. This article reviews the progress resulting from industry adaptation of new regulatory paradigms that include Japan in global drug development programs.
