title: Balancing societal needs and regulatory certainty: the case study of peramivir in Japan.
abstract: Regulators must balance societal and medical requirements against the need for certainty about benefit and risk for new medicines. This is described in a case study of the expedited review and approval of peramivir, a novel neuraminidase inhibitor, in Japan in the context of the emergence of new strain of influenza in 2009. The case illustrates the importance of regulatory science and transparency in supporting such decision making.
authors: Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
authors: T
authors: T
authors: Tominaga
authors: Y
authors: Y
authors: Ando
authors: N
authors: N
authors: Nagai
authors: J
authors: J
authors: Sato
authors: T
authors: T
authors: Kondo
mesh_terms: D000146:Acids, Carbocyclic; D000998:Antiviral Agents / Q000627:therapeutic use; D003517:Cyclopentanes / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006146:Guanidines / Q000627:therapeutic use*; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000187:drug effects; D007251:Influenza, Human / Q000188:drug therapy; D007564:Japan; D020380:Needs Assessment
chemical_list: D000146:Acids, Carbocyclic; D000998:Antiviral Agents; D003517:Cyclopentanes; D006146:Guanidines; C414210:peramivir