Examples
Worked examples
- Is an instance
A Nature contributions statement reading "A.B. and C.D. conceived the study. A.B. performed the experiments. C.D. wrote the manuscript. All authors reviewed and approved the final version." — free text, no CRediT role tags, following the format Nature's policy describes.
- Is an instance
A Nature submission designating two authors as having "contributed equally" and two others as having "jointly supervised the work" — both are explicit designations Nature's authorship policy permits alongside the free-text statement.
Counter-examples
Looks similar, but isn't
- Not an instance
A Nature manuscript submitted with only an author byline and no contributions statement — the statement is a mandatory manuscript component under Nature's editorial policy, not optional supplementary material.
- Not an instance
A request to add a new co-author to a Nature paper after the manuscript has already been accepted — Nature's policy states authorship additions or deletions are not permitted after acceptance; this has to go through a formal post-publication correction instead.
Editorial commentary
A priority review voucher (PRV) is an FDA incentive awarded to the sponsor of an approved drug or biologic that meets the criteria of one of two statutory programs: the rare pediatric disease PRV program or the tropical disease PRV program. The voucher entitles its holder to redeem it for priority review of a different marketing application at a later date — it is not tied to further use of the product that earned it, and it can be sold to another company entirely. That transferability is what makes a PRV functionally different from ordinary priority review designation: it converts a regulatory timeline benefit into a tradable asset.
What counts as a PRV
A PRV is created only when FDA approves a qualifying application under one of two authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act):
- Rare Pediatric Disease PRV program (FD&C Act section 529) — awarded when FDA approves a drug or biologic for a “rare pediatric disease,” a serious or life-threatening condition affecting primarily people age 18 or younger and affecting fewer than 200,000 people in the United States.
- Tropical Disease PRV program (FD&C Act section 524) — awarded when FDA approves a drug or biologic for the prevention or treatment of a specified “tropical disease” (a statutory list including malaria, tuberculosis, Zika, Chagas disease, and several others added over time), where the application contains no active ingredient previously approved in any other application.
Both programs require that the approved application otherwise qualify for priority review consideration on its own merits before FDA will issue the voucher.
What the voucher actually grants
FDA operates two review-timeline goals under the Prescription Drug User Fee Act (PDUFA): a standard review goal of ten months from filing, and a priority review goal of six months from filing, reserved for applications for products that would provide a significant improvement over available therapy. A PRV lets its holder request priority review — the six-month goal — for a subsequent, unrelated marketing application that would not otherwise qualify for it. The voucher does not guarantee approval; it only shortens FDA’s target review clock for that later submission. FDA still charges an additional user fee to redeem a voucher, separate from the standard PDUFA application fee.
Transferability and market value
Unlike priority review designation earned on a product’s own merits, a PRV is explicitly assignable: the sponsor that earns it can use it on a future application of its own, or sell or transfer it to a different company. This created a secondary market in vouchers, since a company with no near-term application to accelerate can still monetize the incentive by selling it to a company that does. Reported sale prices have varied widely with supply and buyer urgency — the highest publicly reported price was $350 million, paid by AbbVie in 2015 for a rare pediatric disease voucher that United Therapeutics earned on its approval of dinutuximab (Unituxin) for neuroblastoma. As more vouchers have been awarded over time, reported per-voucher prices have generally trended down from that peak, though individual transactions still vary considerably.
Current program status
The rare pediatric disease PRV program has been reauthorized multiple times rather than made permanent. It lapsed briefly at the end of 2024 — FDA could not award new vouchers under it after December 20, 2024 — before the Consolidated Appropriations Act, 2026 (enacted February 2026) reauthorized the program, extending FDA’s authority to award new rare pediatric disease vouchers through September 30, 2029. Anyone assessing whether a program in development could still qualify should check the current statutory sunset date directly against FDA’s program page rather than assume indefinite availability, given this history of lapses and reauthorizations. The tropical disease PRV program, established in 2007, has continued without a comparable sunset provision.
How a PRV differs from orphan drug designation
A PRV is easy to conflate with orphan drug designation, but the two are distinct mechanisms that can apply to the same product at different points. Orphan drug designation is requested and granted during development, based on prevalence and scientific rationale, and confers development-stage incentives (tax credits, fee waivers, market exclusivity on approval). A PRV, by contrast, is only awarded at approval, for a narrower subset of rare-pediatric or tropical-disease products, and its main value is a transferable regulatory asset rather than a development-stage incentive. A product can hold orphan drug designation and never generate a PRV (if it isn’t a qualifying pediatric or tropical disease product), and conversely the rare pediatric disease PRV criteria are not identical to orphan disease prevalence criteria, though the two populations overlap substantially in practice.
Why this matters for research administration
For a research administrator or regulatory affairs office supporting a sponsor-investigator or spin-out with a pediatric or tropical disease candidate, PRV eligibility is a real, quantifiable development incentive worth tracking alongside orphan drug and rare pediatric disease designation requests — it can materially change the return calculation for a small institution or company that would otherwise have no near-term use for accelerated review on its own pipeline, since the voucher itself can be sold. It is not, however, a substitute for a scientifically sound priority-review case: the underlying application still has to meet FDA’s substantive approval standards, and the voucher accelerates only the review clock, not the bar for approval.
Frequently Asked Questions
How do you get a priority review voucher?
A PRV is awarded automatically when FDA approves a qualifying application — there is no separate application for the voucher itself. It requires approval of a drug or biologic under either the rare pediatric disease PRV program (a serious or life-threatening condition affecting primarily people age 18 or younger, affecting fewer than 200,000 people in the United States) or the tropical disease PRV program (a listed tropical disease, with no active ingredient previously approved in any other application), and in either case the approved application must independently qualify for priority review consideration.
What is a tropical disease priority review voucher?
It is a PRV awarded under FD&C Act section 524 when FDA approves a drug or biologic for the prevention or treatment of a disease on a statutory tropical disease list — including malaria, tuberculosis, Zika, and Chagas disease, among others added over time — provided the application contains no active ingredient previously approved in any other application. Unlike the rare pediatric disease PRV program, the tropical disease program has no comparable sunset provision.
How much are priority review vouchers worth?
Reported sale prices have varied widely with supply and buyer urgency. The highest publicly reported price is $350 million, paid by AbbVie in 2015 for a rare pediatric disease voucher that United Therapeutics earned on its approval of dinutuximab (Unituxin) for neuroblastoma; as more vouchers have been awarded over time, reported per-voucher prices have generally trended down from that peak.
Is the rare pediatric disease PRV program still active?
Yes. The program lapsed briefly at the end of 2024 — FDA could not award new vouchers under it after December 20, 2024 — before the Consolidated Appropriations Act, 2026 reauthorized it, extending FDA’s authority to award new rare pediatric disease vouchers through September 30, 2029. Given this history of lapses and reauthorizations, anyone assessing whether a program in development could still qualify should check the current statutory sunset date directly against FDA’s program page.
Does a priority review voucher guarantee FDA approval?
No. A PRV only shortens FDA’s target review clock — from the ten-month standard review goal to the six-month priority review goal — for a later, unrelated marketing application. It does not change the substantive approval standards that application still has to meet, and FDA charges an additional user fee to redeem the voucher.
How is a priority review voucher different from orphan drug designation?
They are separate mechanisms that can apply to the same product at different points. Orphan drug designation is requested and granted during development and confers development-stage incentives such as tax credits, fee waivers, and market exclusivity, while a PRV is only awarded at approval, for a narrower subset of rare-pediatric or tropical-disease products, and its main value is a transferable regulatory asset rather than a development-stage incentive.
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="Nature Author Contributions"
vocab-term-identifier="https://casrai.org/dictionary/term/nature-author-contributions" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"@id": "https://casrai.org/dictionary/term/nature-author-contributions",
"name": "Nature Author Contributions",
"identifier": "https://casrai.org/dictionary/term/nature-author-contributions",
"description": "Nature's author contributions policy requires every submitted paper to include a free-text statement describing each author's role, built on authorship criteria drawn from McNutt et al. (2018) rather than ICMJE's four-part test, and without mandating the CRediT taxonomy for the statement itself. It also permits explicit \"contributed equally\" and \"jointly supervised\" co-author designations and prohibits authorship changes after acceptance.",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/credit-extensions#set",
"url": "https://casrai.org/dictionary/term/nature-author-contributions",
"sameAs": [],
"license": "https://creativecommons.org/licenses/by/4.0/",
"publisher": {
"@id": "https://casrai.org/#organization"
},
"dateModified": "2026-08-15T04:35:18",
"inLanguage": "en"
}
