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

Background: Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This stud...

Full description

Bibliographic Details
Main Author: Lexchin, J. (Author)
Format: Article
Language:English
Published: BioMed Central Ltd 2021
Subjects:
Online Access:View Fulltext in Publisher