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American Course on Drug Development and Regulatory Sciences (ACDRS) Special Workshop: Substantial Evidence in 21st Century Regulatory Science - Borrowing Strength from Accumulating Data


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Slides from all presenters are available

The statutory requirement for substantial evidence of effectiveness of a new drug has generally been interpreted to require demonstration of a low probability (p<0.05), assuming non-effectiveness, based on data from two phase III clinical trials.

This Special ACDRS Workshop opens discussion on deriving substantial evidence of effectiveness based on a high probability of effectiveness, utilizing evidence from all reliable sources of effectiveness data.

Date
Thursday, April 21, 2016 - 8:00 am to 4:30 pm

Event Sponsor
American Course on Drug Development and Regulatory Sciences

Location
University of California, Washington Center
1608 Rhode Island Ave NW, Washington DC

Program

Information and Registration