Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications

Author:

Koole Simone N,Huisman Atse H,Timmers Lonneke,Westgeest Hans M,van Breugel Edwin,Sonke Gabe S,van Waalwijk van Doorn-Khosrovani Sahar Barjesteh

Publisher

Elsevier BV

Reference50 articles.

1. Human medicines: highlights of 2021,2022

2. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014–16: cross sectional analysis;Naci;BMJ,2019

3. European marketing authorizations granted based on a single pivotal clinical trial: the rule or the exception?;Morant;Clin Pharmacol Ther,2018

4. Weighing of evidence by health technology assessment bodies: retrospective study of reimbursement recommendations for conditionally approved drugs;Vreman;Clin Pharmacol Ther,2019

5. Precision medicines have faster approvals based on fewer and smaller trials than other medicines;Pregelj;Health Aff (Millwood),2018

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