How Long Does FDA Approval Take? Drugs, Biologics, and Devices

How long FDA approval takes depends on what’s being approved and which pathway it travels. Once an application reaches the agency, a standard new drug review runs about 10 to 12 months, a priority drug review about 6 months, a lower-risk medical device clearance about 3 to 5 months, and a high-risk device review roughly 6 to 10 months. Those windows describe only the final review, not the years of research and clinical testing that come before an application can be filed.

Review Times by Product Type

The FDA sets performance goals for each application category, and those goals are the best baseline for what to expect. Actual times can run longer when the agency requests more data or the applicant needs to resubmit.

New Drug Application (NDA)

A New Drug Application is how a novel drug reaches the market.¹ Under current PDUFA VII goals, the FDA aims to act on 90 percent of standard new molecular entity NDAs within 10 months of the filing date. The filing date falls 60 days after the FDA receives the submission, because the agency spends that time deciding whether the application is complete enough to review. From arrival to decision, that works out to roughly 12 months for a standard-review new molecular entity.² For non-NME applications, such as new formulations of existing drugs, the 10-month goal runs from the date of receipt rather than the filing date.

Priority Review shortens the goal to 6 months from the filing date for drugs that offer a significant improvement over available treatments.³ Actual times drift above the goals. The median time from submission to approval for novel drugs in 2024 was about 11.7 months.

Generic Drug Application (ANDA)

Generic drugs use an abbreviated pathway because the reference drug’s safety and effectiveness are already established. The applicant shows the generic is bioequivalent to the brand-name drug, delivering the same active ingredient at the same rate and to the same extent.⁴ The FDA’s goal is to review standard original ANDAs within 10 months of the submission date.⁵

Biologics License Application (BLA)

Vaccines, gene therapies, and other biological products go through a Biologics License Application, which the FDA evaluates for safety, purity, and potency.⁶ The clock mirrors new drugs: 10 months from the 60-day filing date for standard review, 6 months for priority review.² Biosimilars, the biologic equivalent of generic drugs, also aim for 10 months from the 60-day filing date.⁷

510(k) Clearance for Lower-Risk Devices

Most Class I and Class II medical devices reach the market through a 510(k) premarket notification, where the manufacturer shows the device is substantially equivalent to one already legally marketed.⁸ The FDA clears 90 percent of 510(k) submissions within 90 days and 98 percent within 150 days.⁹ It is one of the fastest pathways to market.

Premarket Approval (PMA) for High-Risk Devices

Class III devices such as implantable pacemakers and certain diagnostic tests require Premarket Approval, which demands clinical evidence of safety and effectiveness.¹⁰ The MDUFA performance goal is a decision within 180 FDA review days when no advisory committee is needed, or 320 FDA review days when one is. The shared total time-to-decision goal for the FDA and industry together is 285 calendar days for applications received in fiscal years 2025 through 2027.¹¹ “FDA review days” exclude time when the clock is paused while the agency waits for additional information, so calendar time from submission to decision usually runs longer.

De Novo Classification for Novel Low-to-Moderate-Risk Devices

When a new device has no legally marketed equivalent but poses only low-to-moderate risk, the manufacturer can use the De Novo pathway instead of the heavier PMA route. The FDA aims to decide De Novo requests within 150 review days, with an initial acceptance screening within 15 calendar days of receipt.¹²

What Comes Before the Review Clock Starts

Most of the time between “we have a promising molecule” and “the FDA approved it” is spent before an application is filed. For a new drug, the path from early laboratory research to approval averages 10 to 15 years. Preclinical animal and lab studies and human clinical trials consume the bulk of that time, and both must be largely complete before the FDA will even accept an application for review.

Human testing starts with an Investigational New Drug (IND) application, which goes into effect 30 days after the FDA receives it unless the agency puts the study on hold.¹³ Clinical trials then unfold in three phases:

Phase 1 tests safety and dosing in 20 to 100 healthy volunteers over several months.
Phase 2 expands to several hundred patients with the target condition to gauge effectiveness, running several months to two years.
Phase 3 enrolls hundreds to thousands of patients across multiple sites to confirm effectiveness and compare against existing treatments, running one to four years.¹⁴

Devices follow a shorter arc because the testing requirements scale with risk. A simple low-risk surgical instrument might need only bench testing and a literature review. A novel implantable heart device could require years of clinical study. The equivalent of an IND for a device is an Investigational Device Exemption (IDE), treated as approved 30 days after the FDA receives it unless the agency notifies the sponsor otherwise.¹⁵ Not every device needs clinical trials at all; many 510(k) submissions rely on bench testing and comparison to an existing device.

Faster Pathways for Serious Conditions

The FDA offers several routes that either compress the review clock or allow earlier access while data continues to build. None eliminate the underlying evidence requirements.

Fast Track is for drugs treating serious conditions that fill an unmet medical need. It provides more frequent FDA meetings during development and the ability to submit portions of the application on a rolling basis.
Breakthrough Therapy is for drugs where early clinical evidence shows substantial improvement over existing treatments. Sponsors get intensive FDA guidance throughout development.
Accelerated Approval allows approval based on a surrogate endpoint reasonably likely to predict clinical benefit, with confirmatory trials required afterward.
Priority Review shortens the FDA’s review goal from 10 months to 6 months. It affects only the review clock, not the development phase.³

Approvals for rare pediatric diseases can also earn the sponsor a Priority Review Voucher, which can be applied to a different product or sold. That voucher program is set to sunset after September 30, 2029.¹⁶

Emergency Use Authorization

When a public health, military, or domestic emergency is declared, the FDA can authorize unapproved products or unapproved uses of approved products without waiting for full review.¹⁷ An Emergency Use Authorization requires a formal declaration by the HHS Secretary that circumstances justify it, followed by the FDA Commissioner’s determination that the product may be effective and that known and potential benefits outweigh its risks.¹⁸ There is no fixed statutory timeline. During the COVID-19 pandemic, vaccine EUAs were issued within weeks of data submission, compared with the roughly 12-month standard review for a biologics application. An EUA is not the same as full approval and can be revoked when the emergency declaration ends.

What Can Stretch the Timeline

Two things extend real-world timelines past the FDA’s goal dates more than anything else: applications that arrive in poor shape, and Complete Response Letters that send the sponsor back for more work.

For new drug and biologics applications, the agency spends the first 60 days on a filing review, checking whether the submission is complete enough to warrant full evaluation. If key data is missing or the application is disorganized, the FDA can issue a Refuse to File letter and send the applicant back to the start.¹⁹ A Refuse to File action means restarting the entire review clock once the problems are fixed.

If the review reaches a decision but the FDA identifies unresolved issues, it issues a Complete Response Letter listing what the applicant needs to fix. This is not a final rejection. The resubmission is classified based on how much work is needed:

Class 1 covers minor issues like labeling changes or small data clarifications, with a 2-month review cycle.
Class 2 covers substantial changes such as new clinical data or major reanalysis, with a 6-month review cycle.²⁰

Some drugs go through multiple cycles before approval, and each cycle adds months or years. If the applicant disagrees with an FDA decision, a formal dispute resolution process allows appeals to higher levels within the agency, with the deciding official expected to respond within 30 calendar days.²¹

Approval Is Not the End

FDA approval doesn’t close the file. Drugs approved under Accelerated Approval can be required to run confirmatory post-market studies verifying the clinical benefit suggested by the surrogate endpoint used during review.²² Under the 2007 FDA Amendments Act, the agency can require post-market safety studies for any approved drug when data suggests a possible serious risk. These studies have no fixed duration.

Device manufacturers face defined reporting deadlines. A device that causes or contributes to a death or serious injury must be reported to the FDA within 30 calendar days. Events requiring immediate corrective action to prevent serious public harm must be reported within 5 work days.²³ The FDA can withdraw a device’s approval if post-market evidence shows it is unsafe or if the original clinical data proves unreliable.²⁴

1
Office of the Law Revision Counsel. 21 USC 355 – New Drugs
2
Food and Drug Administration. PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027
3
U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
4
U.S. Food and Drug Administration. Abbreviated New Drug Application (ANDA)
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U.S. Food and Drug Administration. GDUFA II Submission Review
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Office of the Law Revision Counsel. 42 USC 262 – Regulation of Biological Products
7
Food and Drug Administration. BsUFA III Commitment Letter
8
U.S. Food and Drug Administration. Premarket Notification 510(k)
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U.S. Food and Drug Administration. Analysis of Premarket Review Times Under the 510(k) Program
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Office of the Law Revision Counsel. 21 USC 360e – Premarket Approval
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Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
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U.S. Food and Drug Administration. De Novo Classification Request
13
eCFR. 21 CFR Part 312 – Investigational New Drug Application
14
U.S. Food and Drug Administration. Step 3: Clinical Research
15
U.S. Food and Drug Administration. IDE Approval Process
16
U.S. Food and Drug Administration. Rare Pediatric Disease Designation and Priority Review Voucher Programs
17
Office of the Law Revision Counsel. 21 USC 360bbb-3 – Authorization for Medical Products for Use in Emergencies
18
U.S. Food and Drug Administration. Summary of Process for EUA Issuance
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Food and Drug Administration. Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry
20
eCFR. 21 CFR 314.110 – Complete Response Letter to the Applicant
21
Food and Drug Administration. Formal Dispute Resolution: Sponsor Appeals Above the Division Level
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U.S. Food and Drug Administration. Postmarketing Requirements and Commitments: Introduction
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eCFR. 21 CFR Part 803 – Medical Device Reporting
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eCFR. 21 CFR Part 814 Subpart C – FDA Action on a PMA