A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

Author:

Shah Rashmi R.1,Roberts Samantha A.2,Shah Devron R.1

Affiliation:

1. Rashmi Shah Consultancy Ltd; Gerrards Cross; UK

2. Friends of Cancer Research; Washington, DC; USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference56 articles.

1. Regulatory review of novel therapeutics - comparison of three regulatory agencies;Downing;N Engl J Med,2012

2. Review of novel therapeutics by three regulatory agencies;Downing;N Engl J Med,2012

3. Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice;Trotta;J Clin Oncol,2011

4. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe;Roberts;Health Aff (Millwood),2011

5. Tufts Center for the Study of Drug Development U.S. offers patients faster, greater access to cancer drugs than Europe 2012 14 4 http://csdd.tufts.edu/files/uploads/08_-_july_10,_2012_-_cancer_drugs.pdf

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