Utilisation of Foreign Clinical Data in Japanese New Drug Approval Review: On What Basis Did the Regulatory Agency Accept Them?

By Shunsuke Ono  

International Journal of Pharmaceutical Medicine, Vol. 18, Iss. 3, 2004-01 ,pp. : 159-165

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Debate over FDA drug approval using new `animal rule'

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Inpharma, Vol. 1, Iss. 1379, 2003-01 ,pp. : 4-4

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South Africa is likely to withdraw approval of nevirapine in the prevention of mother-to-child transmission (MTCT) of HIV infections unless Boehringer Ingelheim produces new data to support the use of the drug in this indication

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PharmacoEconomics and Outcomes News, Vol. 1, Iss. 425, 2003-01 ,pp. : 7-7

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Drug Treatment of Encephalopathy Associated with Fulminant Liver Failure

By Tissiéres P.   Devictor D.  

CNS Drugs, Vol. 11, Iss. 5, 1999-05 ,pp. : 335-349

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The US FDA has granted tentative approval to Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for lansoprazole.

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Inpharma, Vol. 1, Iss. 1623, 2008-01 ,pp. : 19-19

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