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  4. What information is provided to sponsors during the human drug product application review process?
  1. FDA Basics for Industry

What information is provided to sponsors during the human drug product application review process?

The New Drug Application (NDA)/ Biologics License Application (BLA) review process is divided into five phases:

  1. filing determination and review planning
  2. review
  3. advisory committee meeting preparation and conduct
  4. action
  5. post-action

The communication timelines and types of notification within each of these phases are outlined in our Manual of Policies and Procedures (MaPP) 4180.4 NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 40KB)

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).

Relevant Resources:

Manual of Policies and Procedures (MaPP) 4180.4 NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 40KB) Click on the “Desk Reference Guide” box within the MaPP

CDER 21st Century Review Process Desk Reference Guide (PDF - 1.21MB)

Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products (PDF - 684KB)

Drug Development in the 21st Century: the Role of the Office of New Drugs (PDF - 600KB)

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