For Industry

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.

Relevant Resources:

NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 36KB)

MaPP 6050.1: Refusal to Accept Applications for Filing from Applicants in Arrears (PDF - 32KB)

MaPP 6030.1: IND Process and Review Procedures (Including Clinical Holds) (PDF - 32KB)

MaPP 6020.5: Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (PDF - 108KB)

MaPP 6010.8: NDAs and BLAs: Communication to Applicants of Planned Review Timelines (PDF - 120KB)

MaPP 6010.5: NDAs: Filing Review Issues (PDF - 108KB)

Page Last Updated: 05/22/2016
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