title: The Impact of Breakthrough Therapy Designation on Development Strategies and Timelines for Nononcology Drugs and Vaccines.
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.1reviewed the impact of BTD on oncology drug development. This article reviews the impact of BTD on development strategies and timelines for nononcology drugs.
authors: Pfizer U.S. Regulatory Policy and Global Intelligence, Groton, Connecticut, USA.
authors: A F
authors: AF
authors: Poirier
authors: Pfizer U.S. Regulatory Policy and Global Intelligence, Groton, Connecticut, USA.
authors: W R
authors: WR
authors: Murphy
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000008:administration & dosage*
chemical_list: D004364:Pharmaceutical Preparations; D014612:Vaccines