From an FDA document:
The document is a draft entitled "Accelerated Approval and Considerations for Determining Whether a
Confirmatory Trial is Underway." https://www.fda.gov/media/184831/download
Here's a good article on the subject:
Quote:.... if appropriate justification is provided, FDA may not require that the
confirmatory trial is “underway” prior to accelerated approval
The document is a draft entitled "Accelerated Approval and Considerations for Determining Whether a
Confirmatory Trial is Underway." https://www.fda.gov/media/184831/download
Here's a good article on the subject:
Quote:
Quote:the FDA maintained its regulatory flexibility, offering various scenarios in which a confirmatory trial may not be needed or should have completed enrollment prior to the associated accelerated approval.
17
