Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015
Nicholas S. Downing, Audrey D. Zhang, Joseph S. Ross
Abstract
Nicholas S. Downing, Audrey D. Zhang, Joseph S. Ross
Abstract
Between 2011 and 2015, the Food and Drug Administration (FDA) approved 170 new therapeutic agents, and the European Medicines Agency (EMA) approved 144. The times for those regulatory reviews were, on average, 60 days shorter at the FDA than at the EMA.
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Between 2011 and 2015, the Food and Drug Administration (FDA) approved 170 new therapeutic agents, and the European Medicines Agency (EMA) approved 144. The times for those regulatory reviews were, on average, 60 days shorter at the FDA than at the EMA.
Key concepts: Medicine, Food and drug administration, Drug approval, Drug, Pharmacology, Regulatory agency, Agency (philosophy), Approved drug