References
- Shah R, Roberts S, Shah D. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors. Br J Clin Pharmacol. 2013;76(3):396–411.
- Trotta F, Leufkens H, Schellens J, Laing R, Tafuri G. Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice. J Clin Oncol. 2011;29(16):2266–72.
- Salcher-Konrad M, Naci H, Davis C. Approval of cancer drugs with uncertain therapeutic value: a comparison of regulatory decisions in Europe and the United States. Milbank Q. 2020;98(4):1219–56.
- U.S. Food and Drug Administration. Accelerated Approval Program 2020. https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program. Accessed 26 Oct.
- Government of Canada. Guidance document: Notice of Compliance with Conditions (NOC/c) 2016. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html. Accessed 14 Sept.
- Gyawali B, Rome B, Kesselheim A. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ. 2021;374:n1959.
- Centre for Innovation in Regulatory Science. New drug approvals in six major authorities 2010–2019: focus on the availability of medicines and company size. London; 2020.
- Chen E, Haslam A, Prasad V. FDA acceptance of surrogate end points for cancer drug approval: 1992–2019. JAMA Intern Med. 2020;180(6):912–4.
- Kemp R, Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?BMC Med. 2017;15:134.
- Gyawali B, Hey S, Kesselheim A. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med. 2019;179(7):906–13.
- Lexchin J. Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study. BMJ Open. 2018;8:e020377.