A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,General Medicine
Link
http://link.springer.com/article/10.1007/s00228-018-2431-7/fulltext.html
Reference51 articles.
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3. Wolfe SM (2013) When EMA and FDA decisions conflict: differences in patients or in regulation? BMJ 347:f5140
4. DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A (2013) Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010). Value Health 16(8):1150–1155
5. Alqahtani S, Seoane-Vazquez E, Rodriguez-Monguio R, Eguale T (2015) Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiol Drug Saf 24(7):709–715
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