Appendix 7-Application Review Process Model.ppt

Application Review Process Model

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Process Submission

Determine Product Safety and Efficacy through Scientific Review

Plan for Review of Application

The activities in this phase relate to the preparation for conducting an efficient product safety and efficacy review, including determining whether the submitted application meets regulatory requirements for filing. The preparation usually includes establishing the review team, which in many cases includes the same resources from the IND phase, identifying and communicating significant deficiencies that potentially would lead to refusing to file the application, and finalizing the schedule for managing the review.

Monitor Review Progress of NDA or BLA Application

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This phase includes an official submission of an NDA/BLA to the CDER, and the start of the review clock. User fees are assessed, if applicable, and the submission is checked for all of the appropriate materials. The PDUFA goals date is set on the date the application is received.

During this phase, CDER evaluates the application through internal and external expert reviews that result in scientific discipline review findings and recommendations for the action to be taken on the application. Generally, this phase includes management of review activities to ensure that reviews are meeting milestones, application amendments received by the CDER are incorporated into the review or relegated to a new review cycle, and that CDER’s position on post-market commitments, proposed labeling, advertising, and promotional material labeling changes is communicated thoroughly.

These activities relate to ensuring the NDA/BLA application review process is progressing according to established milestones, and that issues impacting the review cycle are mitigated according to regulation or policy. This includes activities for maintaining records of progress (e.g. completion dates, submitted materials, etc.) within the regulatory system, generating reports, identifying progress or timeline issues, communicating status and/or issues, and resolving issues.

Ensure Readiness for Application through Pre-Submission Activities

During this phase, applicants may request meetings with CDER prior to the submission of an NDA/BLA to discuss certain aspects of their application. The meetings may include the traditional pre-NDA/BLA meeting, which includes discussion on formatting, content, and the target submission date of the application, as well as the NDA/BLA pre-electronic submission meeting, which focuses on technical navigability and layout of the application to ensure reviewer familiarity with datasets and other submitted information.

Take Official Action on Application

Activities are initiated through an internal wrap-up meeting to discuss any outstanding topics or issues. This phase may include an additional safety conference to discuss any post-market safety insights and assist in developing risk-benefit conclusions for the application. An action letter is prepared to communicate CDER’s action to the applicant, including finalized post-market comments and labeling. A final action package is prepared to be archived.

Complete Post-Action Activities

Focus of this phase in on learning from the review experience and identifying aspects of the review process that could benefit from improvement. This may include a meeting between the applicant and CDER’s, to discuss deficiencies and actions to be taken by the applicant before an application can be approved, or a lessons learned discussion. This phase also recognizes the ongoing activities to ensure accuracy or promotional materials, especially during launch of the approved product.

Collaboration

Innovation

Training

Reporting

CDER CSC�

Review Management

Data Standards

Knowledge Management