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Recently, in the new Prescription Drug User Payments Act (PDUFA VII) authorization program, the U.
S.
Food and Drug Administration (FDA) committed to establishing a Split Real Time Application Review (STAR) pilot program designed to shorten the time from full submission to FDA decision day so that patients can access new therapies
that address unmet medical needs earlier.
The STAR pilot program, which applies to all therapeutic area supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAs), builds on
the Real Time Oncology Review (RTOR) pilot program 。 Previously, the FDA has introduced technology modernization programs, online-based filing capabilities, and the COVID-19 pandemic has promoted the widespread promotion of RTOR programs, so in the RTOR pilot and RTOR oncology expansion practice, FDA realized the advantages of a similar real-time review process to process higher priority applications and determined to be included in the new PDUFA [1] to speed up the review
of some new drugs 。 On October 3, 2022, FDA published detailed eligibility criteria, further explanations, precautions, and other contents of the STAR program plan on its official website [2].
See the original translation
below.
Step-by-step real-time application review (STAR)
overview
overview In line with the Prescription Drug User Fees Act (PDUFA VII) Commitment[3], FDA is establishing a Step-by-Step Real-Time Application Review (STAR) pilot program designed to shorten the time from full submission to action date to allow patients to access treatment earlier and meet unmet medical needs
.
The STAR pilot program will apply to all therapeutic areas of effectiveness supplemental applications and will review individual disciplines
with specific criteria.
Accepted STAR applications will be submitted in a "split" manner, generally in 2 parts, approximately two months
apart.
FDA will begin the review upon receipt of complete Part 1 data and receive a Part 2 submission, the PDUFA review clock will be triggered, and Part 2 information will include a final clinical study report, a comprehensive summary
of safety and efficacy.
The STAR program is available for drugs and biologics and can be used for certain Complementary New Drug Applications (sNDAs) and Supplemental Biologics License Applications (sBLAs)
that propose new uses for existing therapies to address unmet medical needs.
STAR Eligibility Criteria
STAR Eligibility CriteriaSTAR Eligibility CriteriaFDA will consider the application eligible for the STAR Pilot Program if all of the following criteria are met:
1.
There is sufficient and well-controlled clinical research evidence that the drug may have substantial improvements
on relevant clinical endpoints compared to existing therapies.
a.
Breakthrough Therapy Designation (BTD) or Regenerative Medicine Advanced Therapy Designation (RMAT) is not required, but the above criteria
must be met.
(For details, see section 1.
a.
）
2.
The application applies to medications
designed to treat a major illness that does not meet a medical need.
3.
No longer review time (e.
g.
need for risk assessment and mitigation strategies (REMS))
is required for any part of the submission.
4.
Foreign production site inspections that do not involve CMC (i.
e.
, U.
S.
domestic site inspections may be allowed without affecting the acceleration time frame).
(See "Clarification Note" 2 below for details.
)
Clarification of instructions
Clarification of instructions 1.
Applicants should consider the following factors when providing clinical data that "may demonstrate substantial improvement":
a.
STAR's "substantial improvement" eligibility criteria are the same
as those used to qualify for BTD or RMAT.
While FDA generally expects most non-inferiority trials to fail to show substantial improvement, a non-inferiority trial may meet the STAR "substantial improvement" criteria
if a non-inferiority trial has established a efficacy analysis and the results show substantial improvement over existing therapies.
c.
Supplemental applications for effectiveness demonstrated by real-world evidence (RWE) to substantially improve clinical endpoints compared to existing therapies and are not currently included in
STAR application.
STAR application.
Supplemental applications for effectiveness demonstrated by real-world evidence (RWE) to substantially improve clinical endpoints compared to existing therapies are currently excluded from
STAR application.
2.
Applications to participate in the STAR pilot must include a certification statement clarifying that no associated foreign production facility
is involved in the validity supplement.
Once the Part 1 submission is received, FDA will verify
the notarized claim.
If any foreign production facility is involved, the supplement will no longer be eligible
for review by STAR.
3.
The supplementary application must meet the priority review criteria to participate in the STAR program
.
4.
Passing STAR does not guarantee accelerated approval; However, FDA will make every effort to do this
for applications in the STAR program.
In individual cases, the examination process may be extended, for example, when an applicant submits a material amendment
while the outcome of the application is pending.
5.
Approval to participate in the STAR program does not guarantee approval
of the drug application.
Applications must still meet the applicable approval criteria
.
Process considerations
Process considerations 1.
If the applicant believes that the proposed validity supplement meets the criteria listed in the eligibility criteria, the applicant may submit a STAR application in one of the following ways: 1) as a separate conference call request, or 2) as part of a Type B sNDA/sBLA meeting request
.
STAR applications must provide:
Top line results from adequate, well-controlled trials
Proposed label information
A description of the application meeting each STAR standard
2.
For a separate conference call, the only focus and core of the discussion is whether the proposed supplementary application is STAR eligible
.
The call will not keep minutes of the meeting, but a letter
will be sent after the call with the resolution of the meeting.
If applicants wish to discuss other issues (e.
g.
, proposed additional content and format), they must submit a request to participate in the STAR as well as a Type B sNDA/sBLA meeting
.
3.
STAR Section 1 Submissions must include all of the following:
All components of the sNDA/sBLA efficacy supplement application (e.
g.
, complete datasets, proposed labels, clinical protocols and amendments, top-line efficacy and safety results) are not required to submit a final clinical study report from a full, well-controlled trial in support of the proposed efficacy supplement request, as well as an electronic generic technical file (eCTD) module 2 clinical abstract
Top-line result documents for adequate, well-controlled trials and an applicant's general description of efficacy and safety
Clinical protocols and amendments for key trials
Statistical analysis programmes and statistical procedures
Tables, charts, and lists
Summary of deaths
4.
STAR Section 1 submissions should also include the following:
If applicable, the items described in the CDER Draft Guidelines for Biological Research Monitoring (BIMO) Inspection [4] should be made available to facilitate clinical investigator and sponsor/contract research organization inspection assignments
.
This information
is required for all major (i.
e.
critical) trials to support the safety and efficacy of the application.
Please note that applicants can provide locations or links
to these items if the items described in the CDER's draft BIMO guidelines are available elsewhere in the submission in the stated format.
5.
STAR Part 2 submission* must include all of the following:
Clinical research reports
Comprehensive security summary
A comprehensive summary of effectiveness
*FDA must receive Part 2 submissions approximately (but not more than three months) after receipt of the Part 1 submission
.
6.
Once FDA receives a STAR Part 2 submission, the PDUFA review clock begins as it equates to a complete application
.
FDA will communicate its intention
to expedite the review in the submission letter.
7.
If an applicant is disqualified from the STAR Pilot Program due to an incomplete submission, they can still submit a complete application at a later date; However, they will not receive the evaluation benefits
of the STAR programme.
Translated by Zhang Fan
Proofreader: Yang Yuanlin, Ou Qianqian
Responsible editors: Zhang Zhijuan, Liu Fapeng
Resources:
Resources:
[1] Zhilin "Step-by-step submission, rapid review? The FDA's STAR program may be out of reach? 》https://mp.
weixin.
qq.
com/s/Ih4mHeFmZJ3FKCybT79Qig；
weixin.
qq.
com/s/Ih4mHeFmZJ3FKCybT79Qig；
[2] FDA.
Split Real Time Application Review (STAR).
；
Split Real Time Application Review (STAR).
；
[3] Please refer to the PDUFA redelegation performance targets and procedures for fiscal years 2023 to 2027;
[3] Please refer to the PDUFA redelegation performance targets and procedures for fiscal years 2023 to 2027;
[4] Electronic standardized format for NDA and BLA content submitted to CDER for biological research monitoring (BIMO) inspection (February 2018) and relevant technical conformance guidelines for biological research monitoring with technical
specifications.
specifications.
