Priority Review Voucher Fda

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Priority Review Voucher

(3 days ago) The US Congress created the priority review voucher program in 2007 based on a 2006 Health Affairs paper (Ridley et al. 2006).Under the law, following approval by the Food and Drug Administration (FDA) of a treatment for a neglected or rare pediatric disease, the developer receives a voucher for priority review for a different drug.

https://www.priorityreviewvoucher.org/

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Rare Pediatric Disease Priority Review Voucher Program

(11 months ago) Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria.

https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm

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Priority review - Wikipedia

(3 days ago) Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not ...

https://en.wikipedia.org/wiki/Priority_review_voucher

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Tropical Disease Priority Review Voucher Program | FDA

(6 months ago) The Federal Food, Drug, and Cosmetic Act (FD&C Act), section 524, authorizes FDA to award priority review vouchers (PRVs) to sponsors of approved tropical disease product applications that meet ...

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program

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Rare Pediatric Disease Priority Review Vouchers | FDA

(2 months ago) Under section 529, FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-pediatric-disease-priority-review-vouchers

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Tropical Disease Priority Review Vouchers | FDA

(2 months ago) Tropical Disease Priority Review Vouchers; Search for FDA Guidance Documents ... This guidance provides information on the implementation of section 1102 of the Food and Drug Administration ...

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers

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Understanding the FDA's Priority Review Voucher System ...

(5 days ago) It only sets a target of six, rather than 10 months, for FDA review. Priority Voucher Program Attributes. Eligible candidates are granted two vouchers and receive priority review for each voucher: the drug winning a voucher for a neglected or rare disease, and the drug using a voucher for another indication.

https://www.pharmaceuticalprocessingworld.com/understanding-the-fdas-priority-review-voucher-system/

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Rare Pediatric Disease Priority Review Voucher Program ...

(6 months ago) Section 529 provides a process by which sponsors who are interested in receiving rare pediatric disease priority review vouchers may request designation of their drug or biological product ...

https://www.fda.gov/drugs/development-resources/rare-pediatric-disease-priority-review-voucher-program-section-529

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GAO Critiques FDA’s Priority Review Voucher Programs ...

(6 days ago) Priority review vouchers (PRVs) may have little to no effect on drug development, the Government Accountability Office (GAO) concluded in a report released on Friday — although some drugmakers surveyed said otherwise. The FDA created three PRV programs to encourage the development of drugs for certain tropical and rare pediatric diseases.

https://www.fdanews.com/articles/195718-gao-critiques-fdas-priority-review-voucher-programs

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Rare Pediatric Disease (RPD) Designation Program | FDA

(7 months ago) Rare Pediatric Disease (RPD) Designation Program. Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA will award priority review vouchers to sponsors of rare pediatric ...

https://www.fda.gov/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-program

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Priority Review - Food and Drug Administration

(11 months ago) FDA decides on the review designation for every application. However, an applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious ...

https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm

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FDA Priority Review Program - Program Uses & Controversy

(3 days ago) Additionally, the designation of “priority” is also questioned. Many argue that the decision to assign priority to a drug is arbitrary. Priority Review Voucher Program. The FDA offers Priority Review Vouchers (PRVs) as an incentive for companies to invest in new vaccines and drugs to treat neglected tropical diseases (NTDs).

https://www.drugdangers.com/fda/priority-review-program/

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The Value of Priority Review Vouchers – GAO’s Two Cents

(4 days ago) Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce the desired rate of return.

http://www.fdalawblog.net/2020/02/the-value-of-priority-review-vouchers-gaos-two-cents/

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Priority review voucher prices fall again after Spark's ...

(3 days ago) Spark Therapeutics has sold a priority review voucher, entitling the holder to a faster six-month FDA drug review, to Ireland’s Jazz Pharmaceuticals for $110m, a fraction of the price these ...

https://pharmaphorum.com/news/spark-sells-priority-review-voucher-to-jazz/

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FDA Priority Review Vouchers: Hope For Patients With Rare ...

(13 days ago) A priority review voucher is granted by the FDA to a company, for the development of drugs that fall under the category of Rare and Neglected Diseases. A priority review voucher is granted by the FDA to a company, for the development of drugs that fall under the category of Rare and Neglected Diseases.

https://theskepticalchemist.com/fda-priority-review-voucher/

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Federal Register :: Issuance of Priority Review Voucher ...

(6 days ago) The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act),...

https://www.federalregister.gov/documents/2019/10/09/2019-21984/issuance-of-priority-review-voucher-material-threat-medical-countermeasure-product

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U.S. GAO - Drug Development: FDA's Priority Review Voucher ...

(6 days ago) The Food and Drug Administration (FDA) awards priority review vouchers (PRV) to drug sponsors that develop drugs for tropical diseases or rare pediatric diseases or to use as medical countermeasures. The PRV—which can be sold to another drug sponsor—may be redeemed later to receive priority review from FDA with a targeted review time of 6 ...

https://www.gao.gov/products/gao-20-251

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What happened to the value of priority review vouchers (PRV)?

(15 days ago) The FDA Amendments Act of 2007 created an incentive system for drug developers to pursue tropical neglected diseases, whereby upon approval of a product for a designated tropical disease, the drug developer would receive a voucher that could be applied to receive a priority review for another product (Priority Review Voucher, or PRV).

https://www.locustwalk.com/what-happened-to-the-value-of-priority-review-vouchers-prv/

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Rare Pediatric Disease Pediatric Priority Review Vouchers ...

(5 days ago) The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Rare Pediatric Disease Priority Review Vouchers.'' This draft guidance is a revision of the guidance of the same title that published in 2014. This draft guidance provides...

https://www.federalregister.gov/documents/2019/07/30/2019-16262/rare-pediatric-disease-pediatric-priority-review-vouchers-draft-guidance-for-industry-availability

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Regulatory Explainer: Everything You Need to Know About ...

(5 days ago) Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers

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Priority Review Vouchers Have Helped To Improve Access To ...

(3 days ago) The Food and Drug Administration's (FDA) Priority Review Vouchers (PRVs) for neglected tropical diseases (NTDs) are aimed to incentivize pharmaceutical companies to develop drugs or vaccines for NTDs.

https://www.forbes.com/sites/joshuacohen/2019/04/22/priority-review-vouchers-and-access-to-drugs-targeting-neglected-diseases/

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Debate Over the Priority Review Voucher: Wharton Public ...

(11 days ago) Opposition to the Priority Review Voucher The chief opponent of the priority drug review voucher is the FDA itself. Considering that Congress promulgated the priority review system with minimal FDA oversight, the Department holds serious reservations about the efficacy of priority review in its current form.

https://publicpolicy.wharton.upenn.edu/live/news/1764-debate-over-the-priority-review-voucher/for-students/blog/news.php

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Priority Review Voucher Sales Prices Level Off In 2017

(3 days ago) BioMarin Pharmaceutical Inc. 's latest priority review voucher sale is further evidence that the price for the coupons, which entitle the holder to a speedier US FDA review, is leveling off. On Nov. 27, BioMarin announced plans to sell a rare pediatric disease priority review voucher to an undisclosed purchaser for a lump sum payment of $125m.

https://pharmaintelligence.informa.com/resources/product-content/voucher-sales-prices

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Should the FDA Renew its Rare Pediatric Disease Priority ...

(15 days ago) Drug companies receiving a voucher can have any drug reviewed under priority review (getting an FDA decision in six months as opposed to the standard 10 months), or they can sell the voucher to another company. Vouchers may be sold and resold an unlimited number of times. List of Rare Pediatric Disease PRVs Awarded to Date

https://www.pharmalawgrp.com/blog/3/should-the-fda-renew-its-rare-pediatric-disease-priority-review-voucher-program/

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Latest PRV sale further evidence of sliding value ...

(3 days ago) Dive Brief: Priority review vouchers are commanding lower and lower prices in recent sales among drugmakers, suggested the once-coveted regulatory "fast pass" may be less attractive as more are issued by the Food and Drug Administration.

https://www.biopharmadive.com/news/ultragenyx-prv-sale-value-regulation-fast-pass/529221/

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For Sale: FDA Priority Review Vouchers

(3 months ago) When that application is submitted, the FDA accepts the voucher and agrees to review the data in the drug application within 6 months. 2,3 In addition to surrendering the priority review voucher, the pharmaceutical company has to pay the FDA the priority review fee plus the normal new drug user fee.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5551639/

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GAO-20-251, DRUG DEVELOPMENT: FDA’s Priority Review ...

(3 days ago) FDA’s Priority Review Voucher Program s What GAO Found The Food and Drug Administration (FDA) awards priority review vouchers (PRV) to drug sponsors that develop drugstreat for tropical diseases or rare pediatric diseases or to use as medical countermeasures. The PRV—which can be sold to

https://www.gao.gov/assets/710/704207.pdf

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AstraZeneca pays Sobi $95M for priority review voucher ...

(9 days ago) AstraZeneca has struck a $95 million deal to buy a FDA priority review voucher from Swedish Orphan Biovitrum. The purchase comes as AstraZeneca enters a 12-month period in which it plans to file ...

https://www.fiercebiotech.com/biotech/astrazeneca-pays-sobi-95m-for-priority-review-voucher

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Federal Register :: Issuance of Priority Review Voucher ...

(6 days ago) The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act...

https://www.federalregister.gov/documents/2019/06/24/2019-13356/issuance-of-priority-review-voucher-rare-pediatric-disease-product

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That priority review voucher program? The FDA hates it ...

(6 days ago) Earlier this week, Gilead was able to jump ahead on an FDA approval for its new HIV cocktail Odefsey after buying a priority review voucher from Knight Therapeutics for $125 million, underscoring ...

https://www.fiercebiotech.com/r-d/priority-review-voucher-program-fda-hates-it

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Akebia locks down control over partner's new regulatory ...

(6 days ago) The Food and Drug Administration typically takes 10 months to review a drug approval application, though a priority review voucher or designation is supposed to push the agency to cut that time down to six months.

https://www.biopharmadive.com/news/akebia-vifor-review-voucher-anemia-kidney-drug-prv/572467/

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Is the priority review voucher program stimulating new ...

(3 months ago) One such prize is the priority review voucher (PRV) program. Created by Congress in 2007, the PRV program awards a voucher for the priority review of another drug to companies that develop a new drug for a tropical disease, as designated by Congress or the FDA.

https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0006695

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FDA Priority Review Voucher Programs: Incentive for ...

(14 days ago) Voucher prices, for those sold, have steadily risen over time, and the Food and Drug Administration (FDA) has expressed discomfort at losing some of its discretion to award priority review. Recent Legislation. A number of bills have passed and are currently under review that may impact the continuance of the PRV program.

https://avalere.com/insights/fda-priority-review-voucher-programs-incentive-for-industry-to-develop-novel-treatments

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FDA adds 4 tropical diseases to priority review voucher

(6 days ago) “The FDA priority review voucher (PRV) program has been a critical driver of industry engagement in creating new products for solutions for diseases that are rare in the U.S. but can be ...

https://www.healio.com/pediatrics/emerging-diseases/news/online/%7B0016f32e-4a5a-4365-83df-ba021ffd26b8%7D/fda-adds-4-tropical-diseases-to-priority-review-voucher

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Everything Old is New Again: FDA Revises its 2014 Rare ...

(3 days ago) This week, FDA published a revised draft guidance of the original November 2014 draft guidance titled, “Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry” (hereinafter “revised guidance”). This revision was primarily intended to reflect more recent legislative changes from the Advancing Hope Act of 2016, as well as ...

http://www.fdalawblog.net/2019/08/everything-old-is-new-again-fda-revises-its-2014-rare-pediatric-disease-priority-review-voucher-guidance-for-industry/

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AstraZeneca agrees to buy US FDA Priority Review Voucher ...

(6 days ago) AstraZeneca today announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi).

https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-agrees-to-buy-us-fda-priority-review-voucher-from-sobi-22082019.html

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Fee for Using a Rare Pediatric Disease Priority Review ...

(9 days ago) The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act...

https://www.federalregister.gov/documents/2018/09/27/2018-21033/fee-for-using-a-rare-pediatric-disease-priority-review-voucher-in-fiscal-year-2019

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Vifor buys priority review voucher for vadadustat filing ...

(4 days ago) Vifor Pharma has struck a deal to buy a priority review voucher (PRV). The PRV sets Vifor and partner Akebia Therapeutics up to benefit from a fast review at the FDA when they file for approval of ...

https://www.fiercebiotech.com/biotech/vifor-buys-priority-review-voucher-for-undisclosed-filing

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Biohaven Secures Priority Review Voucher (PRV) To Expedite ...

(3 days ago) Biohaven Secures Priority Review Voucher (PRV) To Expedite Regulatory Review Of Rimegepant Zydis ODT New Drug Application-Rimegepant Zydis orally disintegrating tablet (ODT) is Biohaven's lead oral CGRP receptor antagonist drug candidate from its NOJECTION™ migraine platform-A priority review voucher (PRV) entitles the holder to designate a New Drug Application (NDA) for priority review and ...

https://www.biohavenpharma.com/investors/news-events/press-releases/03-18-2019

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Orphan Drugs & Priority Review Vouchers

(17 days ago) The Federal Drug Administration (FDA) is addressing this problem with Priority Voucher Review Programs, whose recipients are awarded expedited FDA review for their future product. These vouchers have specific requirements in place making them applicable only to drugs being developed for overlooked afflictions, also known as “orphan drugs.”

https://scholarblogs.emory.edu/techtransfer/2018/03/orphan-drugs-priority-review-vouchers/

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Notice of Approval of Product Under Voucher: Rare ...

(5 days ago) The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare ...

https://www.federalregister.gov/documents/2019/12/16/2019-27054/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucher

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Shortening the Review Clock: the Latest on Priority Review ...

(3 days ago) The Latest on Priority Review Vouchers Priority review vouchers (PRVs) are a valuable incentive available to companies upon approval of novel drugs to treat rare pediatric diseases or certain tropical diseases. These vouchers can be used on a subsequent application to speed the review process and are an asset that can...

https://camargopharma.com/resources/blog/shortening-review-clock-latest-priority-review-vouchers

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Priority Review Vouchers - Emory University

(3 days ago) September 27, 2007: the Priority Review Voucher program went fully into effect. Sponsors can earn a Priority Review Voucher by obtaining FDA approval for eligible products. Impact. Priority review vouchers were created as an important tool to encourage research and development in the world’s neglected tropical diseases.

http://globalhealthprimer.emory.edu/priority-review-vouchers.html

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The Regulatory Burden Of The Priority Review Voucher ...

(15 days ago) In a recent interview, an official from the Food and Drug Administration (FDA) expressed concern about the costs to the FDA of the priority review voucher program. The director of the Office of ...

https://www.healthaffairs.org/do/10.1377/hblog20151028.051452/full/

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Novartis buys regulatory fast pass for $130M | BioPharma Dive

(3 days ago) Dive Brief: Novartis AG will pay $130 million to acquire a Priority Review Voucher from Ultragenyx Pharmaceutical Inc. in a move likely aimed at accelerating regulatory review for one of several potential blockbuster medicines the Swiss pharma plans to file for approval sometime in 2018.; Ultragenyx received the voucher earlier this year when it secured U.S. approval of its rare pediatric ...

https://www.biopharmadive.com/news/novartis-ultragenyx-priority-review-voucher-sale-130-million/513303/

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Priority Review Voucher Programs Poised For US Legislative ...

(7 days ago) US FDA Priority Review Voucher Fee Continues Drop In FY 2020 Sponsors will pay 12% less to redeem a voucher in FY 2020, which is charged on top of the traditional PDUFA user fee. Rare Pediatric Disease Priority Review Voucher Not Generating New Drug Trials Researchers find no significant difference in number of rare pediatric disease treatments ...

https://pink.pharmaintelligence.informa.com/PS141673/Priority-Review-Voucher-Programs-Poised-For-US-Legislative-Attention-In-2020

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New Fees Announced for Use of Priority-Review Vouchers ...

(3 days ago) In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).). Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for a specific drug or ...

https://www.lachmanconsultants.com/2019/09/new-fees-announced-for-use-of-priority-review-vouchers/

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Creative use of the priority review voucher by public and ...

(3 months ago) The PRV permits priority review of a subsequent NDA for a drug that the FDA would otherwise assign to standard review, thus reducing time-to-market by four to six months. This means gaining a competitive advantage, more sales, and greater profitability. The voucher can be redeemed by the same applicant or can be sold .

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6237288/

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