Potential negative impact of reputed regulators' decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis.
Carlos E DuránMartín CañásMartín UrtasunMonique ElseviersRobert Vander SticheleThierry ChristiaensPublished in: PloS one (2021)
LA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient's care elsewhere.