EMA to open up scientific advice service to non-mandated PASS studies
This article was originally published in SRA
The European Medicines Agency is planning to expand the scope of its scientific advice service by formally including the expertise of its pharmacovigilance committee, PRAC, in the process1. To this end, it will soon launch a 12-month pilot project in which it would encourage drug companies to seek scientific advice for post-authorization safety studies (PASS) with a particular focus on those PASS that are not imposed as a condition for marketing authorization.
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