Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME
Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.
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Recommendations from the European Medicines Agency explain the conditions under which early access to remdesivir could be given through compassionate use programs.
The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.