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FDA Pilot to Gain Experience Reviewing a Small Number of Original Applications following Split Real Time Application Review (STAR) Paradigm

The Food and Drug Administration’s (FDA or Agency) Center for Biologics Evaluation and Research's (CBER) and Center for Drug Evaluation and Research's (CDER) are announcing the opportunity for a limited number of original marketing applications to be submitted and reviewed following the STAR pilot program paradigm. FDA is interested in gaining experience with the STAR pilot program paradigm, which is intended to benefit public health by providing earlier access to therapies that address an unmet medical need.

The PDUFA VII STAR pilot program for certain efficacy supplements continues to be available across all therapeutic areas and review disciplines. General Information about the STAR submission and review paradigm can be found on the FDA STAR webpage.

Starting on December 2, 2024, CDER and CBER will each be accepting, on a voluntary basis, a limited number (1-2) of original marketing applications. Qualified applications will be accepted for this pilot in the following manner: 

  1. The first two proposed applications (for each Center) that qualify based on the acceptance criteria outlined below, and 
  2. The proposed applications having the earliest planned submission date. Applicants will identify the date by which they plan to submit Part 1. If for any reason they are unable to submit by that date, the next qualified applicant in the queue will be accepted instead.

Acceptance criteria:

  • Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies
  • Intended to treat serious condition with an unmet medical need
  • No aspect of the submission is likely to require a longer review time (e.g., requirement for new REMS, etc.)
  • No chemistry, manufacturing, or control information that would require a foreign manufacturing site inspection

If you have questions or are interested in participating in the project for CDER, email ONDExecOPS@fda.hhs.gov.

If you have questions or are interested in participating in the project for CBER, email CBER-RegOps@fda.hhs.gov.

FDA intends to respond within 3-5 business days to acknowledge email inquiries and provide additional information for those interested in potentially participating.

Information submitted pursuant to this effort will be received and maintained in the same manner as any application related submissions.

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