FDA NDA Review Timeline: Standard, Priority, and Expedited

The FDA’s review timeline for a New Drug Application runs about ten months for a standard review and about six months for a priority review, measured from the filing date for new molecular entities and from receipt for other applications. Those figures are performance goals negotiated with industry under the Prescription Drug User Fee Act (PDUFA), not statutory deadlines. The current framework, PDUFA VII, covers fiscal years 2023 through 2027.¹ What follows explains when the clock starts, what can move it, and what the FDA’s recent record against those targets looks like.

When the Clock Starts

For a new molecular entity (NME) NDA or an original biologics license application, the PDUFA review clock does not begin the day the application arrives. The FDA first takes up to 60 days to decide whether the application is complete enough to accept for review.² The ten-month or six-month goal is then measured from that 60-day filing date. For non-NME NDAs and efficacy supplements, the clock runs from the date of receipt.³

Two things can stop the process before the review clock ever starts. If the required user fee is not paid at submission, the process stalls and the clock resets; the Regulatory Project Manager verifies payment within five days of receipt.⁴ For fiscal year 2026, the fee for an NDA requiring clinical data is $4,682,003, and $2,341,002 for one that does not.⁵

Second, if the review team finds the application materially incomplete or poorly organized during the 60-day window, the FDA can issue a Refuse-to-File (RTF) letter. Grounds include missing mandatory sections, insufficient justification for relying on a single clinical trial, missing abuse-potential assessments, and noncompliance with electronic formatting rules.⁶ An applicant who receives an RTF letter has three choices: request an informal conference within 30 days, ask the FDA to file the application “over protest” and be reviewed as-is, or fix the deficiencies and resubmit for a fresh filing determination.⁷

Standard Review vs. Priority Review

Once an application is filed, the FDA aims to act on 90 percent of standard applications within ten months and 90 percent of priority applications within six months of the filing or receipt date.³

Priority review is assigned to drugs that, if approved, would represent a significant improvement in the safety or effectiveness of treating, diagnosing, or preventing a serious condition.⁸ A sponsor can request it, but the FDA makes the determination on its own regardless. Some applications get priority review automatically, including drugs designated as qualified infectious disease products and applications submitted with a priority review voucher.⁹ The FDA notifies the applicant of the designation within 60 days of receipt. Priority review compresses the agency’s timeline. It does not change the scientific standard for approval or the quality of evidence required.

A GAO analysis of 637 NDAs submitted between fiscal years 2014 and 2018 found that once PDUFA target timelines and the number of expedited designations were controlled for, most FDA divisions finished their reviews within two weeks of each other.¹⁰ Features of the application itself, not the reviewing division, drive how long a review takes.

What Happens Between Filing and the Action Date

The review is a parallel effort. Medical officers, chemists, statisticians, pharmacologists, microbiologists, and other specialists each evaluate the portions of the application within their expertise, and their written evaluations move up through team leaders, division directors, and office directors.² The team also reviews proposed labeling, inspects manufacturing facilities, and evaluates whether a risk management strategy is needed.

For NME NDAs and original biologics applications, several communication milestones structure the cycle:

A Day 74 letter from the FDA identifying the planned internal mid-cycle review date and preliminary advisory committee plans.³
A mid-cycle communication call, generally within two weeks of the FDA’s internal mid-cycle meeting (roughly month 5 for standard reviews and month 3 for priority).⁴
A late-cycle meeting before the action date to discuss remaining deficiencies, risk management, and potential post-marketing requirements.³

The FDA may also convene an advisory committee of outside experts. These meetings are public and include consumer and patient representatives.¹¹ Their recommendations are nonbinding; the agency retains sole authority over the final decision.¹²

What Can Push the Action Date Back

Two situations formally extend the PDUFA goal date. The first is a major amendment: significant new information submitted during the review, such as a major new clinical study report, a substantial re-analysis of previously submitted data, or a new risk management strategy. A major amendment extends the goal date by three months for original applications and efficacy supplements, or two months for manufacturing supplements. Only one such extension is permitted per review cycle.³ The RPM must classify the amendment within 14 calendar days and notify the applicant of the new goal date.¹³ GAO data showed that about 12 percent of NDAs submitted between fiscal years 2014 and 2018 involved a major amendment, with the rate varying widely by division.¹⁴

The second is an inspection of a manufacturing facility not identified in the original application, which can trigger an extension of two to three months.³

What Happens at the Goal Date

On or before the PDUFA goal date, the FDA takes one of two actions. It either approves the application, or issues a Complete Response Letter (CRL) telling the applicant the application cannot be approved as filed.¹⁵ A CRL outlines the specific deficiencies identified, which commonly involve safety and efficacy concerns, manufacturing problems, or bioequivalence issues.¹⁶ The letter may include recommendations on how to make the application approvable.

After a CRL, the applicant can resubmit with the deficiencies corrected, withdraw the application without prejudice to a future submission, or request a hearing to contest the denial.¹⁵ If the applicant takes none of those steps within one year, the FDA can treat the application as withdrawn.

A resubmission starts a new review cycle whose length depends on the scope of the changes. A Class 1 resubmission covers only minor items — final labeling, routine safety updates, stability data, or minor re-analyses — and receives a two-month review. A Class 2 resubmission involves anything beyond that, such as new clinical data, a new manufacturing facility, or an advisory committee presentation, and receives a six-month review.¹⁷

Expedited Pathways That Affect the Timeline

Beyond standard and priority review, the FDA operates several programs that can shorten either development or review. They are distinct designations, and a single drug can qualify for more than one.

Fast Track and Rolling Review

Fast track is available for drugs intended to treat serious conditions and fill an unmet medical need. Its most significant procedural benefit is eligibility for rolling review, which lets the sponsor submit completed sections of the NDA as they are finished rather than waiting for the entire package. The FDA begins reviewing each section on receipt, so by the time the final section arrives the agency has already worked through much of the application.¹⁸

Breakthrough Therapy

Breakthrough therapy designation requires preliminary clinical evidence that the drug may offer a substantial improvement over existing treatments on a clinically significant endpoint. It carries all the features of fast track, including rolling review, plus intensive FDA guidance starting as early as Phase 1, involvement of senior managers, and a cross-disciplinary project lead who acts as scientific liaison across review disciplines.¹⁹ The FDA responds to designation requests within 60 days and encourages sponsors to submit them no later than the end-of-Phase 2 meeting.²⁰

Accelerated Approval

Accelerated approval lets drugs for serious conditions with unmet needs be approved based on a surrogate endpoint reasonably likely to predict clinical benefit, rather than a direct measure of how a patient feels or survives.²¹ Drugs approved this way generally must conduct confirmatory trials after approval to verify the predicted clinical benefit.

Real-Time Oncology Review

The Real-Time Oncology Review (RTOR) pilot, launched in February 2018 by the Oncology Center of Excellence, lets the agency begin evaluating pivotal clinical data before the full application is formally submitted. Sponsors submit components of the marketing application in up to three pre-submissions followed by a final submission.²² RTOR does not change PDUFA goal dates, but across the first 20 oncology applications reviewed under the pilot through April 2020, the median time from application submission to FDA approval was 3.3 months.²³

Split Real Time Application Review (STAR)

The STAR pilot, established under PDUFA VII, extends a similar concept to efficacy supplements across all therapeutic areas. An eligible supplement is submitted in two parts roughly two months apart. Part 1 contains datasets, labeling, statistical plans, and key tables; Part 2 contains the final clinical study reports and clinical summaries. The PDUFA clock starts only when Part 2 arrives, but the FDA commits to setting an action date at least one month earlier than the standard six-month priority review goal. Eligibility requires the supplement to be for a serious condition with unmet need, demonstrate substantial improvement over existing therapy, qualify for priority review, and involve no foreign manufacturing sites.²⁴

Project Orbis

Project Orbis, launched in May 2019, coordinates the concurrent submission and review of oncology applications among the FDA and partner regulatory agencies in Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the United Kingdom.²⁵ Each agency makes its own independent approval decision. During the program’s first year, the median time-to-approval was 4.2 months for the FDA and 4.4 months for partner agencies across 60 applications.²⁶

Recent Performance Against the Goals

The FDA’s track record in meeting PDUFA commitments has been strong. In 2024, CDER approved 50 novel drugs, meeting or exceeding goal dates for 47 of them (94 percent). Thirty-seven were approved on the first cycle of review, and 34 were approved in the United States before any other country.²⁷ In 2025, CDER approved 46 novel drugs, met or exceeded goal dates for 44 (96 percent), and achieved first-cycle approval for 39 (85 percent).²⁸ From 2015 through 2024, CDER averaged approximately 47 novel drug approvals per year.

Expedited programs figure heavily in those numbers. In 2025, 33 of the 46 novel drugs (72 percent) used at least one expedited pathway: 21 received priority review, 18 had fast track designation, 15 had breakthrough therapy designation, and 11 received accelerated approval. The agency also issued 19 Complete Response Letters for 18 novel drugs that year, so a meaningful share of applications still do not clear on the first attempt.²⁸ Beginning in September 2025, the FDA started publicly releasing redacted Complete Response Letters for the first time, an effort the agency described as ending the “guessing game” for the broader industry about why drugs are not approved.¹⁶

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eCFR. 21 CFR 314.110 — Complete Response Letter to the Applicant
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FDA. MAPP 6020.4 — Classifying Resubmissions in Response to Complete Response Letters
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FDA. Advancing Health Through Innovation: New Drug Therapy Approvals 2025