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.
Thursday, April 21, 2016 - 8:00 am to 4:30 pm
American Course on Drug Development and Regulatory Sciences
University of California, Washington Center
1608 Rhode Island Ave NW, Washington DC