Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

Author:

Zeitoun Jean-David123,Lefèvre Jérémie H.45,Downing Nicholas S.6,Bergeron Henri17,Ross Joseph S.689

Affiliation:

1. Sciences Po; Paris France

2. Department of Gastroenterology and Nutrition; Saint-Antoine Hospital, APHP; Paris

3. Department of Proctology; Croix Saint-Simon Hospital; Paris France

4. Department of General and Digestive Surgery; Saint-Antoine Hospital, APHP; Paris France

5. University Paris VI; Paris France

6. Center for Outcomes Research and Evaluation; Yale-New Haven Hospital; New Haven Connecticut USA

7. Senior Research Fellow at the National Centre for Scientific Research (CNRS); France

8. Section of General Internal Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine; Yale University School of Medicine

9. Department of Health Policy and Management; Yale University School of Public Health; New Haven Connecticut USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference17 articles.

1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma;Eichler;Nat Rev Drug Discov,2008

2. Adaptive licensing: taking the next step in the evolution of drug approval;Eichler;Clin Pharmacol Ther,2012

3. Expediting drug development - the FDA's new “breakthrough therapy” designation;Sherman;N Engl J Med,2013

4. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000109.jsp&mid=WC0b01ac0580028a47

5. http://ec.europa.eu/health/documents/eudralex/index_en.htm

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