The European Medicines Agency (EMA) released a report on Tuesday that analyzed over 100 applications submitted for medicines in the fields of psychiatry or neurology between 1995 and 2014. In the report, EMA concludes that various challenges can arise in the...
Raps.org journalist, Alexander Gaffney reported that an EU court has surprisingly issued an interim order that the European Medicines Agency (EMA) should stop publishing any more information or documents until a final order has been passed regarding public...
The European Medicines Agency provided draft guidance documents focused on the quality of oral modified release products and transdermal delivery patches last week. The EMA anticipates a response by March 2013. The guidelines for patches are fixed toward developers...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?