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EFSPI comments on FDA coveriate guideline collated
EFSPI Comments on EMA Reflection paper on the use of extrapolation in the development of medicines for paediatrics
EFSPI Comments – ICH draft Concept Paper on choosing appropriate estimands in confirmatory clinical trials
EFSPI Comments – EMA draft guidance on ‘Adjustement for Baseline Covariates’
(EMA/295050/2013)
EFSPI comments on the EMA’s Reflection paper on methodological issues associated with pharmacogenomic biomarkers
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’
EFSPI comments on draft FDA ‘Guidance for Industry – Adaptive Design Clinical Trials for Drugs and Biologics’
EFSPI comments on draft FDA ‘Guidance for Industry – Non-Inferiority Clinical Trials’
EFSPI comments on EMEA CHMP guideline on missing data
EFSPI comments on EMEA CHMP guideline on the investigation of bioequivalence
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Tel: +44(0)1625 664549
Email: admin@efspi.org