"Conditions of Accelerated Approval
1. Promotional Materials
Unless otherwise informed by the Agency, an applicant must submit to the Agency for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, intended for dissemination or publication within 120 days following marketing approval.29 After 120 days following marketing approval, unless otherwise informed by the Agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of the labeling or initial publication of the advertisement.30
2. Confirmatory Trials
For drugs granted accelerated approval, postmarketing confirmatory trials have been required to verify and describe the anticipated effect on IMM or other clinical benefit. These trials must be completed with due diligence.31
FDA has interpreted the due diligence requirement to mean that the postmarketing trial(s) intended to verify the clinical benefit must be conducted promptly to facilitate determination, as soon as possible, of whether clinical benefit has been verified. The protocol for a postmarketing trial should be developed as early as possible, and timelines for the trial should be specified; for example, timelines for enrollment and trial completion should be stipulated. There should be agreement between FDA and the sponsor on the design and conduct of the confirmatory trial(s).
If it is clear during development that a product is intended to be approved under accelerated approval on the basis of a surrogate endpoint or an intermediate clinical endpoint, confirmatory trial(s) should be underway at the time the marketing application is submitted. If it is not clear until shortly before or after submission of a marketing application that a surrogate endpoint or an intermediate clinical endpoint will be the proposed basis for accelerated approval, there should be agreement on the design and conduct of such trial(s) before approval.
Generally, the confirmatory trial would evaluate a clinical endpoint that directly measures clinical benefit. For example, the confirmatory trial population would ordinarily be the same disease population that was studied to support accelerated approval. In some cases, however, the commercial availability of a drug following accelerated approval may make it difficult to enroll patients in the same disease population. In these cases, a confirmatory trial may be conducted in"
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