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Letters Approval of cancer drugs

EMA and FDA decisions based on flawed evidence to approve new cancer drugs negatively affect Latin American patients

BMJ 2019; 367 doi: (Published 15 October 2019) Cite this as: BMJ 2019;367:l6017
  1. Carlos E Durán, doctoral student1,
  2. Martín Cañás, associate professor, coordinator23,
  3. Thierry Christiaens, professor1
  1. 1Heymans Institute for Pharmacology, Ghent University, 9000 Ghent, Belgium
  2. 2Instituto de Ciencias de la Salud, Universidad Nacional Arturo Jauretche, Argentina
  3. 3Pharmacology Area, Federación Médica de la Provincia de Buenos Aires, Argentina
  1. carlos.duran{at}

A recent editorial1 by Mintzes and colleagues warns about using flawed clinical trials to approve new cancer drugs in Europe2 and the US.3 The implications go further, however: during the past decade, several Latin American countries have adopted regulations that abbreviate the approval process of new drugs in the case of earlier approval by the European Medicines Agency (EMA) or …

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