The priority review is granted to applications in which a new indication or new drug product, if
approved, has a potential to present a safe and effective therapy where no satisfactory alternative
exists compared to currently available therapies or marketed products. A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application.
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The priority review is granted to applications in which a new indication or new drug product, ifapproved, has a potential to present a safe and effective...
