The ISSCR Comments on EMA Draft Guidance on Registry-based Studies

Policy
Written By Keith Alm

The ISSCR recently delivered comments on the draft Guideline on Registry-based Studies (EMA/502388/2020). Among other points, the letter stated support the crucial role of the European Medicines Agency (EMA) in overseeing the development of safe and effective new products and the draft Guideline on Registry-based Studies. The Society also encouraged EMA to clarify the appropriate uses for patient registries to prevent them from being abused by businesses seeking to prematurely commercialize unproven stem cell-based interventions.

Read the letter.

Keith Alm
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