A comparison of the Food and Drug Administration's and Health Canada's regulatory decisions about failed confirmatory trials for oncology drugs: an observational study.
Joel R LexchinPublished in: Journal of pharmaceutical policy and practice (2021)
This study shows that decisions made by Health Canada and the FDA about whether to withdraw a drug or remove a failed indication when drug/indications fail a confirmatory trial are usually similar, although the sample size on which this conclusion is made is small. The clinical implications of these similarities and differences should be explored.