How is a sponsor of a product application that is subject to PDUFA target dates informed about whether the review of its product application is on track to meet the target date for FDA action on the application
The review division regulatory project manager (RPM) will inform applicants about major elements of the internal review timeline for each application, anticipating some flexibility for resolution of unanticipated review findings that require adaptation of the review plan. Major review milestone timelines will be conveyed to applicants following review planning. The RPM will communicate any significant changes in the review timeline to the applicant as such changes arise. Changes to the review plan can stem from additional team interactions, interactions with senior management, need for consult input, problems identified during facilities inspections, and requests for additional data or analyses from the applicant.
Communication between applicant representatives and the review division RPM is generally the most effective and timely mechanism for interaction. Applicants are encouraged to work with RPMs, particularly at the time of application submission, to create a clear communication strategy establishing points of contact and methods of communication. The RPM coordinates the review team activities, monitors the overall status of the review, and makes any needed adjustments.
If FDA determines that a decision is not going to be made on the application by the target date, then the RPM will promptly inform the sponsor of that determination and discuss relevant issues.
- SOPP 8401: Administrative Processing of Biologics License Application (BLA) Effective Date: May 1, 2007
- SOPP 8401.1: Issuance and Review of Responses to Information Requests and Discipline Review Letters to Pending Applications Effective Date: Date: June 11, 2002
- SOPP 8401.3: Filing Action: Communication Options Effective Date: August 4, 2010
- SOPP 8405: Complete Review and Issuance of Action Letters Effective Date: September 20, 2004
- Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (PDF - 684KB)