FDA Review Timelines by Pathway and Product Type: Actual Submission-to-Decision Data

How long FDA review actually takes: submission-to-decision times by pathway, review track, and the CNPV pilot

FDA's user-fee goals tell sponsors how long review should take. The dates FDA itself records in approval letters and in its 510(k) and De Novo decision records show how long it did take. This article sets those actual elapsed times against the statutory goal structures for novel drugs and biologics (NME NDAs and original BLAs), 351(k) biosimilars, resubmissions after a complete response, expedited programs, the Commissioner's National Priority Voucher (CNPV) pilot, and 510(k) and De Novo device submissions.

All figures are calendar days from the receipt date FDA states in the approval letter (or in the 510(k)/De Novo record) to the decision date. They are not the same thing as the "FDA days" or "PDUFA clock" metrics FDA uses for goal reporting, and the difference matters. That is explained where it applies.

Key findings

• Priority review delivers novel drug and biologic approvals in about 8 months; standard review takes about 12. Across 109 first-cycle novel approvals (NME NDAs and novel BLAs, January 2024 to September 27, 2026), the median time from receipt to approval was 242 days under priority review and 365 days under standard review. Both distributions are tightly clustered around the goal date.
• Those medians match PDUFA VII almost exactly. FDA's goal for NME NDAs and original BLAs is action within 6 months (priority) or 10 months (standard) of the 60-day filing date, meaning roughly 8 and 12 months from receipt ⁴²⁴⁷.
• Expedited designations do not shorten the review clock by themselves. Breakthrough therapy, fast track, orphan, accelerated approval, rolling review/RTOR, and redeemed priority review vouchers all produced medians of 237 to 243 days among priority-review approvals. The priority designation sets the review time.
• A complete response letter is the single biggest driver of total time. Resubmitted novel applications were approved a median of 182 days after the resubmission arrived, consistent with the 6-month Class 2 goal ⁴²⁴⁷. The total time from original receipt, though, stretched to between 4 and 5 years in the slowest cases.
• Biosimilars run about 12 months first cycle and about 15 months overall. The median first-cycle 351(k) approval took 366 days, in line with the BsUFA III goal of 10 months after the 60-day filing date ⁸⁷³⁴.
• CNPV approvals have come in 44 to 61 days after filing, and 40 to 71 days from receipt. FDA reported approvals 44, 50, 55, and 61 days after filing ^{4235423442428720}. Rasonque came 40 days after receipt ⁸⁷⁶⁹; Foundayo came 71 days after receipt. The clock starts only after a rolling submission is complete, however, and at least one CNPV supplement took 326 days ^87498753.
• 510(k) clearances in 2025 had a median of 126 calendar days from receipt to decision; De Novo grants took about 11 months. Only 35% of 2025 510(k)s were cleared within 90 calendar days, compared with the MDUFA V goal of 90 FDA days ⁸⁷⁴¹. The gap reflects time on hold, which is not counted as FDA days.

The goal framework: what FDA commits to

Because the PDUFA and BsUFA clocks for Program applications start after the 60-day filing period, a "6-month" priority review ends about 8 months after receipt, and a "10-month" standard review ends about 12 months after receipt ^42478734. Device "FDA days" count only the days a submission is under active FDA review. The count starts at receipt of the submission, or at receipt of the amendment that allows it to be accepted ^87428744. Time on hold is excluded ⁸⁷⁴⁵.

Novel drugs and biologics: first-cycle approvals

The table below covers novel approvals from January 2024 through September 27, 2026 that were approved on the first review cycle. Review designation comes from Drugs@FDA, and received dates come from each approval letter.

The interquartile ranges are only about 10 days wide for every priority and standard cohort. In practice, first-cycle approvals land on or just before the PDUFA goal date. Early action is rare. Only two first-cycle novel approvals in the set came in under 180 days, and both were CNPV products (discussed below). Among conventional reviews, the fastest were oncology priority reviews at 189 to 227 days, such as Avmapki Fakzynja Co-Pack at 189 days ⁵⁵¹⁹, Itovebi at 197 days ⁵⁵⁴⁴, and Imdelltra at 217 days ⁵⁷³⁵.

The long tail on standard review reflects extensions and delays that did not end in a formal complete response. Examples include Etcamah at 465 days ⁵⁵²⁹ and Tevimbra, whose BLA was received in July 2021 and approved in March 2024 (975 days) ⁵⁷⁵⁹.

Representative approvals (fastest and slowest first-cycle)

Foundayo is listed in Drugs@FDA as a standard-review NDA ⁵⁵²¹. It was nonetheless approved in 71 days from receipt because it was reviewed under the CNPV pilot ⁵⁸⁵⁰.

Trend by approval year

The median first-cycle time fell from 275 days in 2024 to about 242 to 244 days in 2025 and 2026. This reflects a larger share of priority-review approvals rather than faster action against the goal date. The within-track medians stay pinned to about 8 and 12 months.

Expedited programs: designation versus review time

Among first-cycle, priority-review novel approvals, the expedited designation had essentially no effect on the median time from receipt to approval:

Breakthrough-designated products that received standard review took a median of 365 days (n=6), which is the same as other standard reviews. Breakthrough therapy, fast track, and RTOR deliver their value earlier, through more intensive development-phase interaction, rolling submission, and readiness at filing. They do not compress the PDUFA clock once it starts. Accelerated approval changes the evidentiary basis, not the review duration. A redeemed rare pediatric disease or other priority review voucher converts a standard review into a priority one. It does not produce anything faster than a normal priority review. The voucher-redeemed approvals in this set had a median of 241 days.

Designation status was extracted from FDA review documents and approval letters. Absence of a designation in those documents may reflect incomplete documentation rather than absence of the designation.

Complete responses and resubmissions

Of 136 novel approvals in the period, 27 followed at least one complete response letter.

Once a resubmission arrives, FDA acts on the Class 2 timeline. The median was 182 days from resubmission receipt to approval, and the interquartile range was only 168 to 183 days. A few Class 1 resubmissions closed in about 2 months (minimum 35 days). The real cost of a CRL is the sponsor-side gap between the complete response and the resubmission:

For priority applications, a CRL moves the 75th percentile of total time from original receipt from about 244 days to 294 days. For standard applications it moves from 365 to 456 days. Resubmission approvals for novel products in 2026 had a median resubmission-to-approval time of about 122 days, the shortest of the three years, but the sample is small.

Biosimilars (351(k) BLAs)

First-cycle biosimilar approvals had a median of 366 days from receipt (interquartile range 364 to 456) ^571957385768. That is consistent with the BsUFA III goal of 10 months after the 60-day filing date ⁸⁷³⁴. Resubmissions were common: 14 of 48 biosimilar approvals in the dataset were resubmission approvals, acted on a median of 182 days after resubmission receipt ^574057335746. Including resubmissions, the median total time from original receipt to approval was about 15 months (455.5 days), and the longest case exceeded 11 years ^572456895771.

The Commissioner's National Priority Voucher (CNPV) pilot

How the pilot works

FDA announced the CNPV program on June 17, 2025 ⁴²³⁶ and awarded its first nine vouchers on October 16, 2025 ⁴²³⁸. A second cohort of six followed on November 6, 2025, bringing the total to 15 ⁴²⁴⁰. Vouchers go to drug and biologic applications, including manufacturing and efficacy supplements, that align with national priorities: a U.S. public health crisis, innovative cures, large unmet need, onshoring of manufacturing, or affordability ^42334231.

The target is a decision about 1 to 2 months after filing or final submission, compared with roughly 10 to 12 months under the usual process. FDA may extend the target for incomplete submissions, ambiguous results, manufacturing problems, or complex reviews ^423642384234. Sponsors must provide CMC information and draft labeling at least 60 days before the final submission. FDA's illustrative timeline runs about 60 days for presubmission (longer when foreign inspections are needed), 14 to 21 days for filing, and 30 to 60 days for review ^42334231.

A multidisciplinary team reviews the application concurrently and presents a preliminary recommendation to the CNPV Review Council, a "tumor-board-style" panel of senior FDA leaders. The Council votes on a nonbinding recommendation, and the approval decision stays with the product center ^{4232423142364238}.

Actual CNPV review times

As of March 20, 2026, FDA reported 18 vouchers awarded and four approvals, including two oncology approvals made 44 and 55 days after filing ⁴²⁴². Foundayo's approval came 294 days ahead of its January 20, 2027 PDUFA date ⁴²³⁴. FDA's program page also lists CNPV approvals for higher-dose semaglutide (March 19, 2026), a gene therapy for young children with sickle cell disease (July 1, 2026), and an oral PCSK9 inhibitor (July 17, 2026), but it does not give review durations for them ⁴²³².

Three caveats apply when comparing CNPV times with conventional reviews:

1. The clock starts late. CNPV times are measured from filing or from the final component of a rolling submission. Measured from the first submission, Foundayo took 131 days ^58595848 and Lipfendra 145 days ^57945789. That is still well under a priority review, but not "one month."
2. The clock can be extended. For Tzield S-010, CNPV cut the initial review clock to 4 months, with a goal date of November 21, 2025 ^87568757. A major amendment pushed the goal to April 21, 2026 ^87498755. FDA then missed that date so it could convene an advisory committee ⁸⁷⁵¹, and approved the supplement on June 12, 2026, 326 days after receipt ⁸⁷⁴⁹.
3. Designation labels do not reflect CNPV. Drugs@FDA classifies Foundayo as a standard review ⁵⁵²¹ and records Rasonque as a priority review without a CNPV flag ⁵⁷⁸⁴. Analyses that group by review designation alone will misclassify CNPV approvals as outliers.

Medical devices: 510(k), De Novo and PMA

510(k)

For the 3,197 510(k) decisions dated in calendar year 2025, the median time from receipt to decision was 126 calendar days. The mean was 146 days, the interquartile range 79 to 213 days, and the 90th percentile 267 days ^194722532316. Only 35% were decided within 90 calendar days.

These are total elapsed days, including time on additional-information hold. They are not comparable with the 90-FDA-day goal, which excludes hold time ^87418742. They are closer in concept to MDUFA V's average total time to decision (TTD) target of 112 days for FY2025 ⁸⁷⁴¹. The comparison is only approximate, because MDUFA TTD is reported by receipt cohort, while this analysis groups submissions by decision date ^87428744.

Elapsed time varies widely by device type:

Among the highest-volume product codes, medians ranged from about 3 months (MAX, OHS, GEX, HRS) to 5 to 6 months (QIH, LLZ, DZE). Product code, and the testing and predicate expectations that come with it, is therefore a better planning input than the pathway-wide median.

De Novo

Across 168 De Novo grants decided from January 2022 through September 27, 2026, the median time from receipt to grant was 325.5 days (about 11 months). The interquartile range was 242 to 381 days, and the 90th percentile 623 days ^431743144365.

Only 14 of the 168 grants came within 150 calendar days of receipt. The MDUFA V De Novo goal is 150 FDA days ⁸⁷⁴¹. The gap again reflects hold time and the interactive nature of De Novo review. The fastest grants were diagnostics: Xpert HCV; GeneXpert Xpress System (DEN240016), 72 days ⁴³⁰⁵; MagDI System (DEN240013), 98 days ⁴³⁰⁷; Healgen Rapid Check COVID-19/Flu A&B Antigen Test (DEN240029), 122 days ⁴²⁹⁸.

PMA (original, Class III)

PMA timelines are governed by the MDUFA V goals of 180 FDA days, or 320 FDA days with advisory committee input ^87418742. In calendar time, actual decisions take longer.

Original PMAs, the pathway for the highest-risk Class III devices, show a median filing-to-approval time of about 252 days (8.3 months) in the sampled cohort, but the distribution is heavily right-skewed. The middle half spans roughly 180 to 520 days, and the slowest tail extends well past three years for devices that go through advisory-panel review, major deficiency cycles, or manufacturing follow-up ^87708771. Straightforward PMAs, including several recent cardiovascular and electrophysiology devices, cleared filing to approval in about 6 months ^87728773, while more complex or panel-track submissions such as certain carotid-stent and combination systems ran 3 years or longer ⁸⁷⁷¹. Two cautions apply to the PMA figure: it is measured from the FDA "filing" milestone (after the acceptance and filing review), which understates total submission-to-decision time, and the filing date is documented in only a minority of PMA decision records, so the sample is smaller and less complete than the device-clearance and drug figures.

How to read these numbers

• Calendar days from receipt are not goal-clock days. For drugs, subtract about 60 days to approximate the PDUFA or BsUFA clock for Program applications. For devices, the difference between elapsed time and FDA days is sponsor response time, which can be substantial.
• This covers approvals only. Applications that received a CRL and never came back, were withdrawn, or received a not-substantially-equivalent decision are not captured, so the figures describe successful reviews.
• Rolling submissions compress apparent review time. For CNPV and other rolling reviews, the elapsed time depends on whether you measure from the first module or the last.
• Review designation is the dominant variable for drugs. Once the PDUFA clock starts, priority versus standard, and whether a CRL is issued, explain almost all variation. Expedited designations matter mainly before submission.

For product-specific follow-ups, such as time to approval within a particular review division, the effect of advisory committees on elapsed time, or supplement review times under CNPV compared with conventional efficacy supplements, the underlying approval letters and decision records can be examined application by application.