EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPs
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.
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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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Announcing product milestones and liking LinkedIn posts are just some of the topics addressed in a long-awaited guidance that deals with the challenges prescription drug makers face in the UK when using social media.