Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

Author:

Alqahtani Saad1,Seoane-Vazquez Enrique12,Rodriguez-Monguio Rosa34,Eguale Tewodros125

Affiliation:

1. International Center for Pharmaceutical Economics and Policy; Massachusetts College of Pharmacy and Health Sciences (MCPHS University); Boston MA USA

2. Division of General Medicine and Primary Care; Brigham and Women's Hospital; Boston MA USA

3. School of Public Health and Health Sciences; University of Massachusetts; Amherst MA USA

4. The Institute for Global Health; University of Massachusetts; Amherst MA USA

5. Department of Medicine; McGill University; Montreal Quebec Canada

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference41 articles.

1. The challenge of globalization in pharmaceutical law-is an international drug approval system modeled after the European system worth considering?;Purnhagen;Food Drug Law J,2008

2. Comparison of drug approvals in Europe versus the United States: an analysis of discrepancies between drug products reviewed by EMA and FDA;Makuch;Therapeutic Innovation & Regulatory Science,2014

3. Convergence versus social embeddedness;Saltman;European J Public Health,1997

4. Differences in product information of biopharmaceuticals in the EU and the USA: implications for product development;Nieminen;Eur J Pharm Biopharm,2005

5. What is past is prologue: the international conference on harmonization and lessons learned from European drug regulations harmonization;Lee;University of Pennsylvania Journal of International Economic Law,2005

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