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# FDA Meets STAR Pilot Commitment
- URL: https://www.fdaweb.com/fda-meets-star-pilot-commitment/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152887

FDA is launching a pilot of its Split Real Time Application Review (STAR) program that aims to shorten the time from the date of complete submission to the action date. The program was agreed to in the PDUFA 7 commitment letter.

An agency [announcement](https://www.fda.gov/drugs/development-resources/split-real-time-application-review-star?ref=fdaweb.com) says the STAR pilot will apply to efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria. Accepted STAR applications will be submitted in a “split” fashion, it says, specifically in two parts with the components submitted about two months apart.

FDA says it will begin to review the data once it receives the complete Part 1 submission. The PDUFA review clock will start once the Part 2 submission is received.

The announcement includes STAR eligibility criteria, clarifications, and process considerations.