2017•New England Journal of MedicineRequires access

Regulatory Review of New Therapeutic Agents — FDA versus EMA, 2011–2015

Nicholas S. Downing, Audrey D. Zhang, Joseph S. Ross

Open publisher page 61 citations

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.

About this research paper

What this paper is about

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.

Why it matters

OpenAlex reports 61 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available 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.

Key concepts: Medicine, Food and drug administration, Drug approval, Drug, Pharmacology, Regulatory agency, Agency (philosophy), Approved drug

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