New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments
The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.
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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.