Drug reviews target 6 or 10 months; device paths run 90–180 days, with real timelines shaped by holds, inspections, and quality.
The clock you face depends on what you’re filing and which user-fee program funds the team that reads it. Drug applications sit under PDUFA, generics under GDUFA, biosimilars under BsUFA, and devices under MDUFA. Each program sets goal dates. Plan milestones around these targets.
How Long The FDA Review Takes By Pathway
This quick map lists common pathways and the agency’s action goals. “FDA Days” pause when your file is on hold for an information request.
| Pathway | Target Action Goal | Notes |
|---|---|---|
| New drug or original biologic (standard) | 10 months | Goal to act on application under PDUFA. |
| New drug or original biologic (priority) | 6 months | Reserved for therapies with meaningful advances. |
| Generic drug (standard) | 10 months | Original ANDA goal under GDUFA III. |
| Generic drug (priority & facility pre-coordination) | 8 months | Shorter goal when pre-submission facility steps are met. |
| Biosimilar aBLA (original) | ~10 months | BsUFA III aligns inspections to close by month 10. |
| 510(k) device | 90 FDA Days | Decision goal excludes hold time for AI letters. |
| De Novo device | 150 FDA Days | Time commitment under MDUFA goals. |
| PMA device | 180 days | Regulation sets a 180-day review window. |
| Food additive petition | Statutory 180 days | Real-world average often much longer. |
What “Goal Date” Means In Practice
A goal date is the target for an action letter—approval, complete response, or other outcome. It is not the same as total calendar time. Review clocks stop during your response windows, and they can extend when major amendments land. Pre-approval inspections or a late manufacturing fix often push the action out.
Drug And Biologics Review: Standard, Priority, And Advisory Steps
For original drugs and biologics, the action target is 10 months under the standard track and 6 months when a priority tag applies. The team may convene an advisory committee, and that session often lands weeks before the goal date. When safety, efficacy, or labeling changes arise late in the cycle, the clock can stretch through a major amendment.
Generics follow their own playbook. A standard original ANDA targets an action at 10 months. A priority ANDA can reach an 8-month goal if the sponsor pre-coordinates facility readiness. Major amendments can add months. Many applications still need more than one cycle.
Biosimilars work on BsUFA timelines. The agency plans inspection work so teams finish by month 10, leaving a short window near the end for final fixes. Supplements tied to labeling changes may move faster.
Want a shortcut? The agency’s “priority review” page spells out the 6-month track for therapies that address serious conditions; link texts on that page include definitions and criteria. Priority review policy.
Medical Device Paths: 510(k), De Novo, And PMA
Class II devices commonly use 510(k). The goal is a decision in 90 FDA Days, with days paused while you answer additional-information letters.
Novel moderate-risk products may use De Novo. The time commitment is 150 FDA Days once the file is accepted. Early technical screening can place the file on hold if basic elements are missing.
High-risk devices use PMA. The regulation states a 180-day window after filing, with the outcome ranging from approval to a not-approvable letter. Panel meetings, manufacturing fixes, or design changes can push into supplements and new cycles.
If you need a single device link to bookmark, the 510(k) decision page lists the 90-day goal and defines “FDA Days.” 510(k) decision goal.
What Usually Extends The Timeline
Three themes slow action letters. First, inspection readiness. If a pre-approval inspection finds gaps, the cycle often ends with a complete response. Second, late major amendments. Fresh analyses, new clinical data, or last-minute CMC fixes can reset the schedule. Third, serial information requests. Unclear responses lead to another round and another pause.
Typical Extension Triggers
- Major amendments: Can add months to the goal date under user-fee rules.
- Inspections: Scheduling across multiple sites stretches the cycle.
- Safety signals: New findings prompt labeling work or new analyses.
- Manufacturing changes: Big CMC updates near the end often pull an action out of the window.
- Incomplete eSTAR or eCTD builds: Early holds stop the clock before real review starts.
What Sometimes Speeds Things Up
Early clarity and fit-for-purpose data move files faster. Pre-submission meetings align on endpoints, comparators, human factors work, and analytical plans. Facility readiness avoids late-cycle surprises. For drugs that match public-health priorities, an internal voucher pilot can compress timelines well below the usual window, but this path is narrow and requires strict setup.
Timeline Levers You Control
- Pre-submission strategy: Ask clear questions early and share outlines and datasets.
- Right-sized studies: Match endpoints and power to the claim you want on label.
- CMC discipline: Lock process parameters before validation; avoid late changes.
- Facility readiness: Keep sites inspection-ready and align quality systems with the file.
- Rapid replies: Treat information-request letters like day-zero priorities.
Understanding “FDA Days,” Holds, And Cycles
Across programs, the review clock excludes the time your file spends on hold while you answer questions. Many first cycles end with a complete response, especially in GDUFA and complex products. That doesn’t mean the project stalled; it signals the list of fixes the team needs. Plan budget and runway for at least one cycle in areas with inspections, device testing, or complex clinical endpoints.
Deep Dive: Drugs, Generics, Biosimilars
Original Drugs And Biologics
Standard action targets sit at 10 months. With a priority tag, the goal drops to 6 months. Advisory meetings often land 6–8 weeks before the goal date. The team can extend timelines when late safety, efficacy, or CMC issues surface. If your program includes new sites or novel platforms, bake in time for inspection coordination.
Generics (ANDAs)
Under GDUFA III, the agency plans to act on 90% of standard original ANDAs within 10 months. A priority path can reach 8 months when a pre-submission facility correspondence is complete and accurate. Major amendments can extend the target by many months. Second-cycle actions still run several months, depending on whether an inspection is needed.
Biosimilars (aBLAs)
BsUFA III aligns review and inspection work to finish by month 10. Supplements tied to safety labeling can move in 3 months, with other categories in 4–10 months. Interchangeability and efficacy supplements stay on longer tracks. Expect a late window for final label work once inspections close.
Deep Dive: Devices
510(k) Notifications
The decision goal is 90 FDA Days. That means the team counts calendar days while your file is under review and pauses the count while you respond to additional-information requests. Clear predicate logic, test plans matched to standards, and traceable risk files keep the count moving.
De Novo Requests
For first-of-a-kind moderate-risk products, the commitment is 150 FDA Days after acceptance. A short technical screening checks basic completeness within about two weeks. If gaps show up, the file goes on hold until fixed, and the review days don’t accrue.
Premarket Approval (PMA)
The regulation sets a 180-day window after filing. Large panel packages, manufacturing corrections, or design changes often spill into PMA supplements, which run on their own clocks. Early design history work, stable supplier controls, and clean study datasets reduce churn.
Second Table: Timeline Levers And Typical Impact
| Factor | Typical Impact | What To Do |
|---|---|---|
| Pre-submission meeting quality | Weeks to months saved | Bring crisp questions and share data shells. |
| Facility and inspection readiness | Months saved or lost | Run mock audits; close CAPAs before filing. |
| Major amendment near goal date | Goal extended | Stage changes earlier or split into supplements. |
| eCTD/eSTAR completeness | Days to weeks saved | Automate validation; fix granularity issues up front. |
| Rapid IR responses | Days to weeks saved | Pre-assign SMEs and templates for quick turns. |
| Clear labeling plan | Weeks saved | Align claims to data; draft early and iterate. |
Planning Your Project Against Real-World Time
Set your Gantt on action goals, then add buffers for holds, site visits, and second cycles. Map critical path tasks that often sit off the sponsor side: stability pulls, device bench testing, human factors rounds, and vendor audits. Keep a watch on program updates; user-fee letters and guidance refresh the targets and the way goal dates shift when amendments arrive.
Common Timing Scenarios
Faster-Than-Goal Cases
In rare cases, an internal voucher pilot announced in 2025 compresses drug action targets to one or two months for select national-priority programs. It is non-transferable and uses heavy pre-submission to work. Treat it as an edge case for planning.
Why Food Additive Petitions Stretch
The law sets a 180-day period for review after filing, yet petitions often span two years or more from submission to final rule. The work can involve risk assessments, exposure modeling, and public-comment cycles, which extend the calendar beyond the statute.
Bottom Line: Build Timelines Around Action Goals Plus Real Buffers
PDUFA standard and priority tracks target 10 and 6 months. GDUFA standard original ANDAs target 10 months, with an 8-month route for priority cases that meet facility steps. BsUFA aligns to month-10 action timing. Devices run on 90 FDA Days for 510(k), 150 FDA Days for De Novo, and 180 days for PMA. Food additives can take far longer than the 180-day statute. Plan for holds, inspections, and at least one iteration, and you’ll size your runway with fewer surprises.