Balancing societal needs and regulatory certainty: The case study of peramivir in Japan

Clinical Pharmacology and Therapeutics

Volumn 93, Issue 4, 2013, Pages 342-344

  Tominaga, T ^a   Ando, Y ^a   Nagai, N ^a   Sato, J ^a   Kondo, T ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

PERAMIVIR;

DECISION MAKING; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; HUMAN; INFLUENZA VIRUS A H1N1; JAPAN; LIFE CYCLE; PRIORITY JOURNAL; REVIEW;

ANTIVIRAL AGENTS; CYCLOPENTANES; DRUG APPROVAL; GUANIDINES; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; JAPAN; NEEDS ASSESSMENT;

EID: 84875447235     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.268     Document Type: Review

References (9)

1. World Health Organization. Evolution of a pandemic April 2009-March 2010 . Accessed September 2012.
2. Pharmaceuticals and Medical Devices Agency (PMDA). Report on the Deliberation Results . Accessed September 2012.
3. Pharmaceuticals and Medical Devices Agency (PMDA). Review Report of Rapiacta [in Japanese] . Accessed September 2012.
4. Pharmaceuticals and Medical Devices Agency (PMDA). Review Report of Rapiacta [in Japanese] . Accessed September 2012.
5. Evaluation and Licensing Division and Safety Division, Pharmaceutical and Food Safety Bureau, MHLW. Notification 0113-2, 3. On request to cooperate with peramivir all-case survey (13 January 2010) [Japanese] . Accessed September 2012.
6. US Food and Drug Administration. FDA's Critical Path Initiative . Accessed September 2012.
7. Ministry of Health, Labour and Welfare (MHLW). Basic Principles on Global Clinical Trials (Reference Cases) . Accessed September 2012.
8. Fujita, T. et al. A pharmacoepidemiologic study on the relationship between neuropsychiatric symptoms and therapeutic drugs after influenza infection. Jpn. J. Pharmacoepidemiol. 15, 73-95 (2010).
9. Tominaga, T., Asahina, Y., Uyama, Y. & Kondo, T. Regulatory science as a bridge between science and society. Clin. Pharmacol. Ther. 90, 29-31 (2011).