tetano
Editor, Senior Moderator
Clin Pharmacol Ther. 2013 Jan 15. doi: 10.1038/clpt.2012.268. [Epub ahead of print]
Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan.
Tominaga T, Ando Y, Nagai N, Sato J, Kondo T.
Source
Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, 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.Clinical Pharmacology & Therapeutics (2013); advance online publication 20 February 2013. doi:10.1038/clpt.2012.268.
PMID:
23422872
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23422872
Balancing Societal Needs and Regulatory Certainty: The Case Study of Peramivir in Japan.
Tominaga T, Ando Y, Nagai N, Sato J, Kondo T.
Source
Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, 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.Clinical Pharmacology & Therapeutics (2013); advance online publication 20 February 2013. doi:10.1038/clpt.2012.268.
PMID:
23422872
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23422872