The top documents tagged [accelerated approval]

Pembrolizumab - “Treatment of melanoma has never been this promising”
Documents Pembrolizumab - “Treatment of melanoma has never been this promising”

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Orphan Drugs
Education Orphan Drugs

349 views

A-1 Q-Pan H5N1 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Donna Boyce Head North America, Global Regulatory Affairs GlaxoSmithKline Vaccines
Documents A-1 Q-Pan H5N1 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Donna Boyce Head North America, Global Regulatory Affairs GlaxoSmithKline Vaccines

216 views

Accelerated Approval Update 2005 Ramzi Dagher, MD DDOP/OODP/CDER/FDA
Documents Accelerated Approval Update 2005 Ramzi Dagher, MD DDOP/OODP/CDER/FDA

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TB Drug Co-Development Roundtable: TMC207 (bedaquiline) Chrispin Kambili, M.D. CPTR meeting Oct 04, 2012 0 To edit footers: "insert tab>header and footer"
Documents TB Drug Co-Development Roundtable: TMC207 (bedaquiline) Chrispin Kambili, M.D. CPTR meeting Oct 04, 2012 0 To edit footers: "insert tab>header and footer"

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Have FDA Expedited Programs Shortened Drug Development Timelines? An analysis of newly approved therapies and how FDA expedited programs impacted drug
Documents Have FDA Expedited Programs Shortened Drug Development Timelines? An analysis of newly approved therapies and how FDA expedited programs impacted drug

217 views

Wednesday, December 17, 2014 3:00pm-4:30pm EST National Coalition for Cancer Survivorship Post-Training Webinar ©2014 National Coalition for Cancer Survivorship
Documents Wednesday, December 17, 2014 3:00pm-4:30pm EST National Coalition for Cancer Survivorship Post-Training Webinar ©2014 National Coalition for Cancer Survivorship

216 views

Surrogate Endpoints. The Surrogates Story 3 Drug Trials 2 FDA Policy Issues 1. CAST Trial –Cardiac Arrhythmias 2. Concorde – AZT for AIDS 3. Erythropoietin
Documents Surrogate Endpoints. The Surrogates Story 3 Drug Trials 2 FDA Policy Issues 1. CAST Trial –Cardiac Arrhythmias 2. Concorde – AZT for AIDS 3. Erythropoietin

214 views

Challenges in Utilizing Accelerated Approval Robert J. Temple, M.D. Deputy Center Director for Clinical Science Center for Drug Evaluation and Research
Documents Challenges in Utilizing Accelerated Approval Robert J. Temple, M.D. Deputy Center Director for Clinical Science Center for Drug Evaluation and Research

214 views

1 November 2005 ODAC: DOXIL ®, AIDS-related KS ODAC Discussion on Accelerated Approval 8 November 2005 DOXIL ® (doxorubicin HCl liposome injection) Treatment
Documents 1 November 2005 ODAC: DOXIL ®, AIDS-related KS ODAC Discussion on Accelerated Approval 8 November 2005 DOXIL ® (doxorubicin HCl liposome injection) Treatment

218 views

1 March 2003 ODAC: DOXIL ®, Ovarian Cancer ODAC Discussion on Accelerated Approval March 12-13, 2003 DOXIL ® (doxorubicin HCl liposome injection) Treatment
Documents 1 March 2003 ODAC: DOXIL ®, Ovarian Cancer ODAC Discussion on Accelerated Approval March 12-13, 2003 DOXIL ® (doxorubicin HCl liposome injection) Treatment

217 views

Endocrinologic & Metabolic Drugs Advisory Committee Meeting Fabrazyme ® (agalsidase beta) January 13, 2003 Alison Lawton Senior Vice President Regulatory
Documents Endocrinologic & Metabolic Drugs Advisory Committee Meeting Fabrazyme ® (agalsidase beta) January 13, 2003 Alison Lawton Senior Vice President Regulatory

216 views