How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers’ views

Author:

Tafuri G.,Stolk P.,Trotta F.,Putzeist M.,Leufkens H.G.,Laing R.O.,De Allegri M.

Funder

Escher

Dutch Top Institute Pharma

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference9 articles.

1. European Medicines Agency. Benefit-Risk Methodology Project. EMEA/108979/2009.

2. US Food and Drug Administration. Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. PDUFA V Plan (FY 2013–2017)

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. Qualitative Evaluation and Research Methods;Patton,1990

5. The Discovery of Grounded Theory: Strategies for Qualitative Research;Gasler,2012

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