![](/images/icons/PDFIcon.png) |
EFSPI comments on FDA coveriate guideline collated
|
![](/images/icons/PDFIcon.png) |
EFSPI Comments on EMA Reflection paper on the use of extrapolation in the development of medicines for paediatrics |
![](/images/icons/PDFIcon.png) |
EFSPI Comments - ICH draft Concept Paper on choosing appropriate estimands in confirmatory clinical trials |
![](/images/icons/PDFIcon.png) |
EFSPI Comments - EMA draft guidance on 'Adjustement for Baseline Covariates' (EMA/295050/2013) |
![](/images/icons/PDFIcon.png) |
EFSPI comments on the EMA's Reflection paper on methodological issues associated with pharmacogenomic biomarkers |
![](/images/icons/PDFIcon.png) |
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' |
![](/images/icons/PDFIcon.png) |
EFSPI comments on draft FDA 'Guidance for Industry – Adaptive Design Clinical Trials for Drugs and Biologics' |
![](/images/icons/PDFIcon.png) |
EFSPI comments on draft FDA 'Guidance for Industry - Non-Inferiority Clinical Trials' |
![](/images/icons/PDFIcon.png) |
EFSPI comments on EMEA CHMP guideline on missing data |
![](/images/icons/PDFIcon.png) |
EFSPI comments on EMEA CHMP guideline on the investigation of bioequivalence |