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FDA Review of NDA 21-304 Valganciclovir for the Treatment of CMV Retinitis in AIDS

FDA Review of NDA 21-304 Valganciclovir for the Treatment of CMV Retinitis in AIDS. Joseph Toerner, MD Medical Officer DAVDP. EFFICACY Induction therapy W V15376 Maintenance therapy Pharmacokinetic data. SAFETY Study W V15376 Study W V15705 Single-arm safety study Study PV16000

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585 views • 34 slides

ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003

ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003. Renzo Canetta, M.D. Vice President Life Cycle Management and Clinical Design & Evaluation Oncology Bristol-Myers Squibb Pharmaceutical Research Institute Wallingford, CT, USA. US Europe Japan .

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198 views • 10 slides

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Registrational trials - PowerPoint PPT Presentation

FDA Review of NDA 21-304 Valganciclovir for the Treatment of CMV Retinitis in AIDS

ASCO/FDA Workshop on Lung Cancer Endpoints Alexandria, VA April 15, 2003