What information and types of notifications are provided to sponsors during the human biologic product application review process?
CBER uses the managed review process for both New Drug Applications (NDA) and Biologics License Applications (BLA) to ensure consistency in the process to the extent possible. The communication timelines, including the initial filing letter with the STN assignment and contract information and other types of notification within each of these phases are outlined in our Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products. More detailed information may be found in our manual of Standard Operating Procedures and Policies.
The communication timelines are goals and other factors may impact FDA’s ability to meet those internal goals. These timelines may require modification by the review division based on factors such as staffing, competing workload, and complexity of the application. Such deviations are carefully considered, however, and any new internal timelines are clearly communicated to the review team and applicant by the regulatory project manager (RPM). Agency contact information for the RPM assigned to each application is provided to the applicant in the acknowledgement letter.
- 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)