Program Description

In October 2022, under the Prescription Drug User Fee Act reauthorization (PDUFA VII), FDA launched the Split Real Time Application Review (STAR) pilot program, which aims to shorten the time from the complete submission date to the action date and ultimately allow earlier patient access to therapies that address an unmet medical need. The pilot program applies to efficacy supplements that meet specific criteria across all therapeutic areas and review disciplines. Sponsors of accepted applications would submit materials in two parts, approximately two months apart. The relevant review office or division within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will review these applications.

As part of PDUFA VII, FDA committed to conducting an interim assessment of the STAR pilot program by the end of fiscal year (FY) 2025. This webpage summarizes the findings of FDA’s interim assessment. FDA also committed to holding a public workshop by March 31, 2026, to discuss the potential value and feasibility of expanding the pilot program to select New Molecular Entity (NME) New Drug Applications (NDAs) and Biologic License Applications (BLAs). As of the end of FY25, FDA has not had any applications in the pilot program (see below for more details). For that reason, FDA and industry agreed to cancel the workshop. This website update provides public transparency regarding the pilot’s status and serves to announce that a public workshop will not be held. 

Program Timeline and Assessment Period

FDA launched the STAR pilot program in October 2022 and will accept applications until September 30, 2027. For the purposes of this interim assessment, FDA evaluated the period from the pilot's launch in 2022 through September 30, 2025 (end of FY 2025). This assessment period encompasses the first three years of program availability under PDUFA VII, which provides adequate time to identify trends in industry engagement.

Key Assessment Findings

Program Participation Overview

Despite several FDA presentations on STAR, and the program's availability across all therapeutic areas and review disciplines in CDER and CBER, FDA observed minimal industry interest in the program during the assessment period, as evidenced by the limited number of STAR Entry requests received. Additionally, none of the requests received met the criteria for acceptance into the pilot program. As a result, FDA received no applications in the pilot program as of the end of FY2025.

Submission and Acceptance Data

Analysis of STAR Entry Request Outcomes

Of the six STAR Entry requests received, one was voluntarily withdrawn from consideration by the sponsor.

The remaining five requests failed to meet at least one of the established eligibility criteria and were therefore denied entry into the STAR pilot program.

The specific reasons for denial included one or more of the following:

• Clinical evidence from adequate and well-controlled investigation(s) failed to demonstrate there may be substantial improvement on a clinically relevant endpoint over available therapies.
• Failure to address a serious condition with an unmet medical need.
• One or more aspects of the proposed marketing application would require longer review timelines, which would negate the intended benefits of the split review process.

Implications for Program Design

Potential explanations for the lack of participation and failure of requests to meet eligibility criteria could include a lack of alignment between the STAR program design and sponsor needs for efficacy supplement reviews, as well as differences of interpretation in the eligibility criteria.

Stakeholder Engagement and Feedback

Webinars

In June 2023, FDA presented a webinar on the STAR program and held a Q&A as part of the CDER Small Business & Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Annual Conference.

Later, to address the limited requests for STAR and increase program awareness, FDA hosted a targeted outreach webinar in February 2024, with member companies from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO). FDA recorded the webinar and made it publicly available for subsequent viewing. During the webinar, FDA provided a comprehensive program overview, answered frequently asked questions, and facilitated direct dialogue between FDA and industry stakeholders regarding participation barriers and program optimization opportunities.

A survey administered during the webinar (n=39 respondents) revealed valuable insights into industry perspectives on the program. While a majority of respondents (65%) indicated that they considered applying to the STAR pilot, they faced significant barriers to actual participation. Sixty-seven percent of respondents reported that they prefer to use the Real Time Oncology Review (RTOR) program (as opposed to STAR) for oncologic drug development programs.

Survey responses also indicated potential pathways for enhancing program attractiveness and use. Stakeholders expressed that broadening the program scope to include initial NDAs and BLAs could significantly encourage industry participation.

In September 2024, FDA again presented a webinar on the STAR program as part of the Regulatory Affairs Professionals Society (RAPS) meeting, which draws multiple industry stakeholders.

FDA Pilot for Original Applications

In November 2024, based on feedback from the February 2024 webinar survey and recognizing the need to evaluate the STAR pilot paradigm's applicability beyond efficacy supplements, FDA announced a limited opportunity for original marketing applications to follow a STAR-like submission and review approach on a voluntary basis starting December 2, 2024. This FDA pilot, which was separate from the PDUFA VII commitment, was intended to provide FDA with direct experience applying the split review approach to NDAs and BLAs.

Results

Despite FDA efforts to expand opportunities for industry to submit initial NDAs or BLAs for review under a similar approach to the STAR pilot program, FDA did not receive any formal requests to participate in the STAR-like initiative for original marketing applications. This outcome further reinforces the limited industry interest in the STAR pilot program and suggests that barriers to participation or lack of perceived value extend beyond the scope of efficacy supplements alone.

Conclusion and Next Steps

Assessment Constraints

Given the lack of applications entering the STAR pilot program, FDA is unable to conduct a comprehensive assessment of the program's experiences, internal operational impacts, and clinical or regulatory outcomes.

Public Workshop and Final Report Decision

Under PDUFA VII, FDA committed to hosting a public workshop by March 31, 2026, and producing a final report on the STAR pilot. Based on the results of the interim assessment, FDA has determined that conducting the public workshop and producing a final report would not provide meaningful information to stakeholders beyond updated postings to the public website. Furthermore, based on FDA’s experience with the STAR-like pilot initiative for original applications, the answer seems clear on "the potential value and feasibility of expanding the pilot program to select New Molecular Entity (NME) New Drug Applications (NDAs) and Biologic License Applications (BLAs)".

This decision to refrain from holding a public workshop represents FDA's commitment to fiscal responsibility and efficient use of both agency and stakeholder resources.

Program Status and Future Considerations

As part of the PDUFA VII commitment letter, the STAR pilot program will remain available for eligible efficacy supplements through the remainder of the PDUFA VII commitment period.

FDA will consider the future of the pilot program as part of PDUFA VIII negotiations, considering the observations and experiences outlined in this update.