Snapshot

The Split Real-Time Application Review (STAR) Program pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where The STAR pilot program will apply to efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The following steps summarize the process for applying to and participating in the STAR program: a. An applicant who believes an efficacy supplement qualifies for review under the STAR program will request an informal pre-submission teleconference with FDA and provide FDA with topline trial results and proposed labeling. Alternatively, the preliminary discussion may take place as part of a pre-sNDA/sBLA meeting. b. If FDA agrees that the pre-submission request meets the STAR program eligibility criteria, the application will be accepted into the STAR program, and the applicant will agree to provide the complete application in two parts (these two parts are described under the Split Submission Components* section below or as agreed to with the Review Division). c. FDA will initiate review of the data upon receipt of the Part 1 submission. d. The PDUFA timeline will begin upon receipt of the Part 2 submission (which completes the application). FDA intends to follow the expedited review timelines. These timelines target taking an action at least 1 month earlier than the applicable PDUFA goal date. e. The filing meeting will be scheduled within 30 days of FDA’s receipt of the Part 2 submission. During the filing meeting, FDA will determine an action date at least 1 month in advance of the priority 6-month PDUFA goal date. FDA will notify the applicant of the intended action date in the filing letter. The PDUFA goal date will remain unchanged. *Split Submission Components: Applications reviewed under the STAR program will comprise two separate submissions. a. The Part 1 submission initiates FDA’s review and will contain: All components of the NDA/BLA efficacy supplement (e.g., complete datasets, proposed labeling, clinical protocols and amendments, topline efficacy and safety results), except for final clinical study reports for the adequate and well-controlled investigation(s) supporting the proposed claim and the eCTD module 2 clinical summaries, and A document providing topline results for each of the adequate and well controlled investigations will also be provided in the Part 1 submission. Any modifications to submission content are at the discretion of the OND/CDER clinical division or CBER review office and must be agreed to in advance. b. The Part 2 submission initiates the PDUFA timeline and will contain: The clinical study reports for the adequate and well-controlled investigation(s) (e.g., Phase 3 studies) intended to support the proposed indication, and The eCTD module 2 clinical summaries not included in the Part 1 submission. Part 1 will be submitted approximately 2 months, and not longer than 3 months, in advance of Part 2. If the Part 1 submission is incomplete (i.e., it does not include every component described above, except for easily correctable minor deficiencies of components not essential to initiating review, as determined by the OND/CDER division or CBER review office), the review will not be initiated until the application is complete and the application will no longer be considered within the STAR program.