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Title Submitted File
EFSPI Comments - EMA draft Guideline 'on the investigation of subgroups in confirmatory clinical trials' (EMA/CHMP/539146/2013) July 2014 VIEW DOCUMENT
EFSPI Comments - ICH draft Concept Paper on choosing appropriate estimands in confirmatory clinical trials April 2014 VIEW DOCUMENT
EFSPI Comments - EMA draft guidance on 'Adjustement for Baseline Covariates' (EMA/295050/2013) December 2013 VIEW DOCUMENT
EFSPI comments on the EMA's Reflection paper on methodological issues associated with pharmacogenomic biomarkers October 2011 VIEW DOCUMENT
EFSPI comments on EMA 'Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available' March 2011 VIEW DOCUMENT
EFSPI comments on draft FDA 'Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics' July 2010 VIEW DOCUMENT
EFSPI comments on draft FDA 'Guidance for Industry - Non-Inferiority Clinical Trials' May 2010 VIEW DOCUMENT
EFSPI comments on EMEA CHMP guideline on missing data December 2009 VIEW DOCUMENT
EFSPI comments on EMEA CHMP guideline on the investigation of bioequivalence January 2009 VIEW DOCUMENT