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Pembrolizumab - “Treatment of melanoma has never been this promising”
Pembrolizumab - “Treatment of melanoma has never been this promising”
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Orphan Drugs
Orphan Drugs
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A-1 Q-Pan H5N1 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Donna Boyce Head North America, Global Regulatory Affairs GlaxoSmithKline Vaccines.
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.
Accelerated Approval Update 2005 Ramzi Dagher, MD DDOP/OODP/CDER/FDA.
235 views
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"
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.
Have FDA Expedited Programs Shortened Drug Development Timelines? An analysis of newly approved therapies and how FDA expedited programs impacted drug.
217 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.
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
Meeting Agenda Presentations on endpoints –Regulatory issues –Scientific issues Pros and cons of end points –Classical end points –Non-classical end points.
Meeting Agenda Presentations on endpoints –Regulatory issues –Scientific issues Pros and cons of end points –Classical end points –Non-classical end points.
217 views
Accessing the Accelerated Approval Pathway with a Rare Neurologic Disease Batten Disease June 29-30, 2010 FDA Public Meeting “Considerations regarding.
Accessing the Accelerated Approval Pathway with a Rare Neurologic Disease Batten Disease June 29-30, 2010 FDA Public Meeting “Considerations regarding.
212 views
Patient Reported Outcomes in Oncology Trials Virginia Kwitkowski Clinical Reviewer-- FDA Division of Drug Oncology Products Member OND Patient Reported.
Patient Reported Outcomes in Oncology Trials Virginia Kwitkowski Clinical Reviewer-- FDA Division of Drug Oncology Products Member OND Patient Reported.
214 views
Entrepreneurship in Biotechnology Columbia University Graduate School of Arts and Sciences BIOT 4180 Columbia University GSAS BIOT 4180.
Entrepreneurship in Biotechnology Columbia University Graduate School of Arts and Sciences BIOT 4180 Columbia University GSAS BIOT 4180.
215 views
GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.
GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.
216 views