Pediatric Rare Disease Voucher

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Pediatric Rare Disease Voucher | Coupon Codes

(4 months ago) CouponLx is one-stop service where you can grasp up to 80% OFF discounts, voucher code and coupon code for anything you want to purchase online.

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Pediatric Rare Disease Voucher | Discount Codes

(4 months ago) You’ve found out a reliable place to enjoy all verified coupon and discount codes. Spend less and save more by applying coupon code at checkout.

https://www.couponpublish.com/

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Pediatric Rare Disease Voucher | Promo Codes

(4 months ago) Must-stop destination for online shopping. Let’s join this coupon marathon to win coupons and voucher codes, saving your budget.

https://couponmedical.com/

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Pediatric Rare Disease Voucher | Voucher Codes

(4 months ago) This marvellous space is for adventurous shoppers who seek for valid coupon codes and discounts as final treasure.

https://couponou.com/

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Rare Pediatric Disease Priority Review Voucher Program

(10 months ago) General questions related to the rare pediatric disease priority review voucher program can be directed to OOPD at [email protected] or 301-796-8660 or to CDER's Rare Diseases Program at ...

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

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Priority review - Wikipedia

(10 days ago) The pediatric voucher program includes changes to the voucher program. First, the pediatric treatment developer can ask the FDA in advance for an indication of whether the disease qualifies as a rare, pediatric disease. The awardee must market the drug within 365 days of approval, or the voucher may be revoked.

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

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Rare Pediatric Disease PRVs: FDA Updates Guidance | RAPS

(5 days ago) After 30 September 2020, FDA may only award a voucher if the drug has rare pediatric disease designation and that designation was granted by 30 September 2020, the draft adds. FDA also includes revisions in the draft based on FDA’s experience with implementing the rare pediatric disease PRV program, including voucher request procedures.

https://www.raps.org/news-and-articles/news-articles/2019/7/rare-pediatric-disease-prvs-fda-updates-guidance

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

(3 days ago) Vouchers may be sold and resold an unlimited number of times. List of Rare Pediatric Disease PRVs Awarded to Date. As of January 2019, the FDA has given out 25 PRVs, 17 (68%) of them under the Rare Pediatric Disease Program. So far, drug companies have redeemed at least six of the 17 rare pediatric vouchers for priority review.

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

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Federal Register :: Fee for Using a Rare Pediatric Disease ...

(3 days ago) The sponsor that uses a rare pediatric disease priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a rare pediatric disease priority review user fee in addition to any user fee required by PDUFA for the application.

https://www.federalregister.gov/documents/2019/09/30/2019-21197/fee-for-using-a-rare-pediatric-disease-priority-review-voucher-in-fiscal-year-2020

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FDA wants to nix voucher program for rare pediatric ...

(7 days ago) T he Food and Drug Administration wants to end a voucher program designed to spur development of new drugs for rare pediatric diseases, although a new government report released on Wednesday said ...

https://www.statnews.com/pharmalot/2016/03/03/fda-pediatric-disease-gao/

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Priority Review Voucher

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

(2 days ago) Spark got its priority review voucher for getting its eye disease gene therapy Luxturna approved late last year, and the FDA had issued 19 such vouchers for paediatric rare diseases, under a ...

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

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

(3 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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Uncertainty around the pediatric priority review voucher ...

(7 days ago) The Rare Pediatric Disease Priority Review Voucher (PRV) program has been a lightning rod within the orphan drug sector, and pending Congressional action, the program is set (at presstime) to sunset on October 1. Designed to spur innovation in the …

https://pharmaceuticalcommerce.com/brand-marketing-communications/uncertainty-around-pediatric-priority-review-voucher-prv-program/

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Sarepta Seeks Payday Through Sale Of FDA Voucher - NPR

(5 days ago) Sarepta Seeks Payday Through Sale Of FDA Voucher : Shots - Health News A voucher awarded to a company that finds a treatment for a rare childhood disease can be sold to the highest bidder and then ...

https://www.npr.org/sections/health-shots/2016/09/29/495904450/are-golden-tickets-that-speed-drugs-through-fda-worthwhile

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The Program Stimulating Research Into Tropical and Rare ...

(16 days ago) The rare pediatric disease portion of the PRV program was scheduled to expire at the end of September 2016. However, President Obama signed a bill to extend the program by 3 months, presumably for further evaluation and possible adjustment. 5. The ideas behind the PRV voucher program are laudable.

https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2016/12/the-program-stimulating-research-into-tropical-and-rare-pediatric-diseases

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

(14 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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Ultragenyx Sells Priority Review Voucher for $130 million ...

(15 days ago) NOVATO, Calif., Dec. 18, 2017 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis for $130,000,000.

http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-sells-priority-review-voucher-130-million

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Sevuparin receives Rare Pediatric Disease Designation from ...

(13 days ago) If a drug candidate with a rare pediatric disease designation receives marketing approval in the US, the FDA may issue a Priority Review Voucher to the sponsor company. This voucher can be redeemed to provide Priority Review of a subsequent marketing application for a different product from Modus Therapeutics or another company.

https://www.modustx.com/sevuparin-receives-rare-pediatric-disease-designation-fda-treatment-children-sickle-cell-disease/

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More than 15 million sick children need Congress to act ...

(6 days ago) More than 15 million sick children need Congress to act before Sept. 30 by reauthorizing the Rare Disease Pediatric Review Voucher Program. Not doing so would be neglecting a vital resource in the nation’s ongoing research for rare pediatric diseases.

https://rarediseases.org/hill-publishes-nord-op-ed-congress-must-act-now-help-15-million-sick-children/

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Butterfield Introduces Bill to Support Children with ...

(15 days ago) The Creating Hope Act incentivizes the pharmaceutical industry to develop drugs for children with cancer and other life-threatening illnesses through the rare pediatric disease priority review voucher program at the U.S. Food and Drug Administration (FDA). Pediatric cancer remains the number one disease that leads to the death of American children.

https://butterfield.house.gov/media-center/press-releases/butterfield-introduces-bill-to-support-children-with-cancer-and-other

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Rare Pediatric Disease (RPD) Designation Program | FDA

(6 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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Rare Pediatric Disease Pediatric Priority Review Vouchers ...

(2 days ago) Burden Estimate: This draft guidance on Rare Pediatric Disease Priority Review Vouchers is intended to assist developers of rare pediatric disease products in assessing whether their product may be eligible for rare pediatric disease designation and a rare pediatric disease priority review voucher.

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 ...

(3 days ago) The agency's rare pediatric disease voucher guidance contains similar language: "Although FDA's goal is to take action on the application within 6 months after the 60 day filing period for an application involving a new molecular entity or within 6 months after the date of receipt of an application not involving a new molecular entity, this ...

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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ProQR Receives Rare Pediatric Disease Designation from FDA ...

(22 days ago) Under the RPD program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review by ...

https://finance.yahoo.com/news/proqr-receives-rare-pediatric-disease-120000581.html

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U.S. GAO - Rare Diseases: Too Early to Gauge Effectiveness ...

(3 days ago) It is too early to gauge whether the Food and Drug Administration's (FDA) pediatric voucher program has stimulated the development of drugs to treat or prevent rare pediatric diseases. Given that the typical drug development process often exceeds a decade, insufficient time has elapsed to determine whether the 3 year-old program has been effective.

https://www.gao.gov/products/GAO-16-319

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The Pediatric Voucher Program and Its Impending Renewal ...

(6 days ago) If passed, the pediatric voucher program would be extended until September 30, 2022, with the caveat that if a drug is designated as a drug for a rare pediatric disease by September 30, 2022, it remains eligible for a pediatric voucher so long as it is approved by September 30, 2027.

http://www.fdalawblog.net/2016/09/the-pediatric-voucher-program-and-its-impending-renewal-deadline/

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FDA Clarifies Its Rare Pediatric Disease Priority Review ...

(3 days ago) We posted here an in-depth discussion of the Rare Pediatric Disease Priority Review Voucher (“Pediatric PRV”) program in comparison to the earlier implemented Tropical Disease PRV program. As a short recap, the Pediatric PRV program was created in 2012 to encourage development of treatments for rare pediatric diseases.

http://www.fdalawblog.net/2014/11/fda-clarifies-its-rare-pediatric-disease-priority-review-voucher-program/

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FDA's rare disease pediatric voucher program could become ...

(1 months ago) The bill was intended to encourage development of drugs for pediatric diseases, which affect 200,000 children or fewer in the U.S. To date, the FDA has issued six priority review vouchers, three of which have been rare pediatric disease vouchers. Because of a sunset clause, the program is due to expire on March 17, 2016.

https://www.biopharmadive.com/news/fdas-rare-disease-pediatric-voucher-program-could-become-permanent/379180/

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pediatric rare disease voucher Archives - Page 85 of 85 ...

(1 months ago) Rare diseases are also characterized by a broad range of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. It is estimated that globally 350 million people suffer from rare diseases and 50 percent of them are children.

https://www.biopharmaglobal.com/tag/pediatric-rare-disease-voucher/page/85/

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Obama extends controversial program for rare pediatric drugs

(4 days ago) At issue is the pediatric review program, which was created in 2012 and awards a voucher to a drug maker that wins approval of a treatment for a rare pediatric disease, an area of drug development ...

https://www.statnews.com/pharmalot/2016/09/30/obama-pediatric-drugs-voucher/

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pediatric rare disease voucher Archives - Page 86 of 87 ...

(3 days ago) Home pediatric rare disease voucher. Posts tagged: pediatric rare disease voucher. Cell-penetrating antibodies could crack ‘undruggable’ cancer mutation . May 20, 2017. by administrator Uncategorized. RAS mutations have long been an attractive target in cancer treatment, but scientists have struggled to find a drug that safely combats their ...

https://www.biopharmaglobal.com/tag/pediatric-rare-disease-voucher/page/86/

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Rare Diseases | Regulation | Pink Sheet

(5 days ago) The voucher program was extended to rare pediatric diseases in the FDA Safety and Innovation Act of 2012 and, most recently, to medical countermeasures in the 21 st Century Cures Act, which was signed into law in December 2016. Ridley asserts that sales prices were to were too high in 2015 and 2016 given the supply of rare pediatric vouchers.

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

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Spark Therapeutics Sells Priority Review Voucher for $110 ...

(14 days ago) Under the PRV program, a sponsor who receives FDA approval for a rare pediatric disease drug or biologic may qualify for a voucher to be redeemed at a future time for priority review of a ...

https://www.globenewswire.com/news-release/2018/04/30/1489798/0/en/Spark-Therapeutics-Sells-Priority-Review-Voucher-for-110-Million.html

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Tropical or Rare Pediatric Disease Priority Review ...

(6 days ago) Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway While the United States market for drugs and biologics targeting tropical or rare pediatric diseases is very small, developing novel therapies for patients in these underrepresented groups can be advantageous for both ...

https://camargopharma.com/resources/blog/tropical-rare-pediatric-disease-priority-review-vouchers-update-use-505b2-pathway

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FDA Publishes Guidance On Priority Review Vouchers For ...

(12 days ago) The FDA also maintains a voucher program for tropical diseases, and some lawmakers are attempting to add the Ebola virus to the list. Rare Pediatric Disease Priority Review Program. Pursuant to section 529 of FDASIA, the FDA conducts a priority review voucher program for rare pediatric diseases. The new guidance covers that program.

https://www.outsourcedpharma.com/doc/fda-publishes-guidance-priority-review-vouchers-pediatric-diseases-0001

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Understanding The FDA Priority Review Voucher Program ...

(15 days ago) (The Rare Pediatric Disease Priority Review Voucher Program is currently administered as part of the FDA’s Office of Orphan Products Development.) In 2014, the Adding Ebola to the FDA Priority Review Voucher Program Act was signed into law, expanding the tropical disease voucher program and also making some notable changes to the program.

https://www.infodesk.com/life-sciences/understanding-the-fda-priority-review-voucher-program/

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Newron Receives FDA Rare Pediatric Disease Designation for ...

(9 days ago) The Rare Pediatric Disease designation provides incentives to advance the development of rare disease drugs and biologics. Additionally, the FDA’s Rare Pediatric Disease Priority Review Voucher Program states that a sponsor with a Rare Pediatric Disease designation who receives marketing approval for a rare

https://www.drugs.com/clinical_trials/newron-receives-fda-rare-pediatric-designation-sarizotan-rett-syndrome-18361.html

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FDA Updates Guidance on Rare Pediatric Disease Priority ...

(4 days ago) Drugmakers have been given more clarity on the FDA’s definition of rare pediatric disease and the process for its priority review voucher program in draft revised guidance. The guidance addresses drug companies’ confusion over whether sponsors must receive a rare pediatric disease designation to be eligible for a voucher. At present, the designation is not required to receive a voucher.

https://www.fdanews.com/articles/192300-fda-updates-guidance-on-rare-pediatric-disease-priority-review-voucher-program

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Spark Therapeutics Receives Rare Pediatric Disease ...

(15 days ago) Under FDA's Rare Pediatric Disease Priority Review Voucher program, companies who receive approval for a new drug application or Biologics License Application (BLA) for a rare pediatric disease ...

https://www.globenewswire.com/news-release/2017/07/20/1054633/0/en/Spark-Therapeutics-Receives-Rare-Pediatric-Disease-Designation-for-Investigational-LUXTURNA-voretigene-neparvovec-from-FDA.html

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Rare Pediatric Disease Priority Voucher – What Will You ...

(1 months ago) Today, the FDA announced the 2015 fee for the use of a Rare Pediatric Disease Voucher in a Federal Register (FR) notice ().Created by the FDA Safety and Innovation Act (FDASIA), this program provides a voucher to a sponsor that gains approval for an NDA for a product used to treat an indication that has been classified as a rare pediatric disease.

https://www.lachmanconsultants.com/2014/10/rare-pediatric-disease-priority-voucher-what-will-you-pay-for-speed-2/

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FDA Grants Rare Pediatric Disease Status to ...

(3 days ago) The U.S. Food and Drug Administration (FDA) granted rare pediatric disease designation to ARU-1801, Aruvant’s experimental gene therapy for the treatment of sickle cell disease (SCD) and beta-thalassemia.. This designation means the company will be eligible to receive a priority review voucher once the FDA approves a biologics license application for ARU-1801.

https://sicklecellanemianews.com/2020/01/09/aravant-sickle-cell-therapy-gets-fda-rare-pediatric-disease-designation/

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Rare Disease Patient Advocate Applauds FDA’s Rare ...

(1 months ago) As a rare disease patient advocate—having watched for more than 20 years the struggle for funding of drug development for drugs with small patient populations—I’m glad to see the new FDA Rare Pediatric Disease Voucher Program used for the first time.

https://www.medidata.com/en/blog/rare-disease-patient-advocate-applauds-fdas-rare-pediatric-disease-voucher-program/

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

(13 days ago) The GAO concluded that it's still to early to tell if the pediatric voucher program, designed to encourage developers to jump into rare pediatric diseases by awarding a voucher that automatically ...

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

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FDA Grants Mirum Rare Pediatric Disease Designation for ...

(18 days ago) The designation makes maralixibat eligible for a Rare Pediatric Disease Priority Review voucher upon approval of the therapy by the FDA. The vouchers can be used to reduce the time of an FDA new drug approval review to six months from ten months. The vouchers are potentially lucrative because they are transferable.

https://globalgenes.org/2019/12/16/fda-grants-mirum-rare-pediatric-disease-designation-for-maralixibat-in-alagille-syndrome/

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Sickle Cell Drug Candidate Granted FDA Rare Pediatric ...

(6 days ago) The U.S. Food and Drug Administration (FDA) granted rare pediatric disease designation to IMR-687, Imara’s drug candidate for the treatment of sickle cell disease (SCD). The investigational therapy has also been granted orphan drug status by the FDA. Rare pediatric disease designation is granted...

https://sicklecellanemianews.com/2017/05/16/imaras-imr-687-for-sickle-cell-disease-granted-rare-pediatric-disease-designation/

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Rare Pediatric Disease Priority Review Voucher Archives ...

(19 days ago) Unanimous vote extends the Rare Pediatric Disease Priority Review Voucher Program with important policy changes through December. Washington, D.C., September 23, 2016 – On Thursday, the Senate reached an important compromise to accelerate new treatments to help 15 million sick children with rare diseases.

https://rarediseases.org/tag/rare-pediatric-disease-priority-review-voucher/

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Enzyvant Receives FDA Rare Pediatric Disease Designation ...

(19 days ago) The FDA grants Rare Pediatric Disease designation to therapeutics intended to treat serious or life-threatening rare diseases which primarily affect individuals under the age of 18. With this designation, RVT-802 will be eligible to receive a rare pediatric disease priority review voucher upon BLA approval.

https://roivant.com/enzyvant-receives-fda-rare-pediatric-disease-designation-investigational-therapy-rvt-802/

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FDA's Rare Disease Program: A Rare Opportunity to Help Kids

(24 days ago) The first drug to come out of the FDA's rare pediatric disease priority review voucher program offers hope for patients with a rare progressive type of lysosomal storage disease.

https://www.medscape.com/viewarticle/821918

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Retrophin Closes Sale of Priority Review Voucher ...

(2 years ago) A voucher may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License ...

http://www.businesswire.com/news/home/20150706005719/en/Retrophin-Closes-Sale-Priority-Review-Voucher

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FDA Grants Rare Pediatric Disease Designation to ArQule's ...

(1 months ago) BURLINGTON, Mass.--(BUSINESS WIRE)-- ArQule, Inc. (Nasdaq: ARQL) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to miransertib (ARQ 092) for the treatment of Proteus syndrome. Under the FDA's rare pediatric disease priority review voucher program, the sponsor may be eligible for a voucher that can be used to obtain priority ...

http://investors.arqule.com/news-releases/news-release-details/fda-grants-rare-pediatric-disease-designation-arqules

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21 U.S. Code § 360ff - Priority review to encourage ...

(3 days ago) The sponsor of a rare pediatric disease product application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

https://www.law.cornell.edu/uscode/text/21/360ff

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