Drugs
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4th Annual FDA/DIA Statistics Forum: Integrating Knowledge in Clinical Development: Meta-analysis, Non-Inferiority, and Related Topics - The FDA/HHS Presentations
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Current Challenges in Drug Regulation (PDF - 141KB)Janet Woodcock, M.D., FDA Adjusting to emerging science and expectations of life cycle drug evaluation: The Integration of Information (PDF - 2.8MB)Robert T. O'Neill, Ph.D., FDA Clinical Perspectives on FDA Guidance for Industry: Diabetes Mellitus-Evaluating CV Risk in New Anti-diabetic Therapies to Treat T2DM (PDF - 144KB)Mary H. Parks, M.D., FDA FDA's Draft Guidance for Industry: Non-Inferiority Clinical Trials-Some key statistical issues and concepts (PDF - 349KB)Robert T. O'Neill, Ph.D., FDA FDA Guidance on Non-Inferiority Trials: General Issues (PDF - 220KB)Robert J. Temple, M.D., FDA Challenges of Meta Analysis for Determining Non-inferiority Margin (PDF - 339KB)H.M. James Hung, Ph.D., FDA Learn-Apply Paradigm: Re-configuring Drug Development Goals (PDF - 1.1MB)Joga Gobburu, FDA Diagnostic Devices for Tailoring Therapies (PDF - 278KB)Gene Pennello, Ph.D., FDA Study Data Specifications and ADaM Review and Comparison (PDF - 143KB)Joy Mele, FDA HIV Efficacy Data Specification (PDF - 142KB)Wen Zeng, Greg Soon, FDA Collaboration: Can We Make It Happen? Finding a Solution for Analytical Tool Development and Distribution (PDF - 1.9MB)Matt Soukup, Ph.D., FDA Comparative Effectiveness Research (PDF - 299KB)Robert J. Temple, M.D., FDA Comparative Effectiveness 101 (with Statistical Applications) (PDF - 947KB)Anne Trontell, MD, MPH, AHRQ
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