Developments in Quantitative Drug Safety Evaluation, Perspectives from a Regulator
View Presentation *Mark Steven Levenson, CDER/FDA Keywords: safety, meta-analysis, observational studies, Sentinel In the last 10 years, several internal and external events, initiatives, and actions have increased the resources and efforts devoted to the evaluation of drug safety in both the premarket and post-market life-cycles of drugs at the Center for Drug Evaluation and Research (CDER). Biostatistics at CDER has had a large role in these efforts. Biostatistics support in quantitative drug safety has included the design and analysis of (1) large outcome trials, (2) meta-analyses, and (3) observational studies. The talk will present examples in these areas. The talk will also describe recent initiatives including Sentinel, the development of the meta-analysis for safety guidance, and the guidance for establishing the cardiovascular safety of diabetic therapies. Finally, the talk will discuss future directions and challenges in the area of quantitative drug safety.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC