1443:. Priority review does not omit safety or efficacy studies or require approval within a given time frame. It sets a target of 6 rather than 10 months for FDA review. Nevertheless, a study in 2008 claimed that new molecular entities approved in the two months before the first review deadlines showed a higher rate of postmarketing safety problems than drugs approved at other times. Nardinelli and colleagues (2008) of the FDA, however, wrote that they were not able to replicate the findings and that the findings might be driven by HIV-AIDS therapies. Following the Nardinelli piece, Carpenter acknowledged several errors in their data set and demonstrated errors in the FDA's and Nardinelli's data; Carpenter and colleagues report that the original associations between last-minute approvals and safety problems hold.
1463:"Some of the highest-leverage work that government can do is to set policy and disburse funds in ways that create market incentives for business activity that improves the lives of the poor. Under a law signed by President Bush last year, any drug company that develops a new treatment for a neglected disease like malaria or TB can get priority review from the Food and Drug Administration for another product they've made. If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier. This priority review could be worth hundreds of millions of dollars."
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38:
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products that haven't previously been approved for any indications. Economists at Duke
University, who published on this concept in 2006, estimated that priority review can cut the FDA review process from an average of 18 months down to six months, shortening by as much as a full year the time it takes for the company's drug to reach the market.
2463:
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treatment, prevention, or diagnosis of disease; elimination or substantial reduction of a treatment-limiting drug reaction; documented enhancement of patient willingness or ability to take the drug according to the required schedule and dose; or evidence of safety and effectiveness in a new subpopulation, such as children.
1431:
Critics have claimed a number of issues with the priority review program. First, the priority review voucher might be too small or too large to encourage drug development. It may be too small because tropical diseases with incredible burdens can be presumed to merit more resources. This is likely not
159:
When seeking approval for a drug, manufacturers can apply to the FDA for priority review. This is granted when a drug is intended to treat a serious condition and would "provide a significant improvement in safety or effectiveness" over currently available treatments. A priority review voucher can be
1422:
Pediatric rare diseases are any disease that primarily affects people under the age of 18 and affects 200,000 or fewer people in the United States. Medical countermeasures are drugs to be used "in the event of a public health emergency stemming from a terrorist attack with a biological, chemical, or
1212:
Writing in The Lancet, David Ridley and
Alfonso Calles Sánchez proposed extending the voucher to the European Union. The proposed EU voucher would provide priority regulatory review through the European Medicines Agency, as well as accelerated pricing and reimbursement decisions by EU member states.
1203:
The Senate's
Medical Countermeasure Innovation Act of 2016 proposed adding a new category of drugs to the priority review voucher program. In 2016, it was confirmed that the approval of drugs for medical countermeasures would be eligible to earn a priority review voucher. Medical countermeasures are
1190:
on
November 12, 2014. President Obama signed it on December 16, and it became Public Law 113-233. Forty-five Senators cosponsored the bill (26 Democrats and 19 Republicans). This act also eliminated the differences between tropical disease and pediatric disease vouchers, but allowing both to be sold
1166:
The awardee must market the drug within 365 days of approval, or the voucher may be revoked. Within five years of approval, the manufacturer must submit a report containing information on the estimated population in the United States suffering from the rare pediatric disease, the estimated demand in
1446:
There have also been complaints that the priority review voucher encourages innovation, but does not pay for access to existing therapies. Funding from governments or foundations might be needed to purchase treatments for poor people. Aidan Hollis of the
University of Calgary has commented that the
236:
An intangible benefit of the voucher is the value created for a company if the faster review provides them "first mover advantage," allowing the voucher holder's product to be introduced ahead of a similar, competing product. By taking advantage of existing market forces, patients in the developing
1228:
article raised concerns about the sale of these vouchers, given that they "require the FDA to shorten its decision deadline to six months from the standard 10 months—potentially giving companies an extra four months' worth of sales," but also noted that a voucher is not a guarantee of FDA approval
204:
A request for
Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company's request whether a priority or standard review designation will be assigned. Designation of a drug as "priority" does not
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A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The 2002 amendments to PDUFA set a goal that a standard review of a new drug application be accomplished within a ten-month time frame. The FDA goal for
1158:
In 2012, President Obama signed into law the FDA Safety and
Innovation Act which includes Section 908, the "Rare Pediatric Disease Priority Review Voucher Incentive Program". Section 529 extends the voucher program to rare pediatric diseases, but only on a trial basis. After the third voucher is
232:
Under current
Prescription Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead of the standard ten-month review period. Actual FDA review timelines, however, can be longer than the target PDUFA review periods, particularly for new
252:
Companies that use the voucher will be required to pay a supplemental priority review user fee to ensure that the FDA can recoup the costs incurred by the agency for the faster review, in addition to the fee for standard review of drugs. The additional user fee also aims to ensure that the new
240:
Sponsors must inform the FDA of their intention to use a priority review voucher 90 days before submission. Before the Adding Ebola to the FDA Priority Review
Voucher Program Act in 2014, this requirement was 365 days, which was a hindrance to the process of speedy review, as companies do not
200:
The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment. Such advances can be demonstrated by, for example: evidence of increased effectiveness in
1221:
Because
Priority Review Vouchers (PRVs) may be sold, a secondary market for the vouchers has emerged, and their value has increased, although the market for the vouchers is limited. Companies use the sale of PRVs to recoup expenses undertaken for drug research and development. A 2015
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the case for pediatric rare diseases, some drugs are developed for pediatric use through expansion of adult drug research for similar conditions. The priority review voucher might be too large, if it rewards research which would have been done anyway, or research with low value.
180:
cycle sponsors may use the possibility of earning a voucher in their valuation of their company, a requirement of a marketing plan and reporting of marketing, and indefinite transferability of the voucher. In 2016, medical countermeasures were added to the program.
1447:
proposal does not address "the access problem, but helps to increase incentives through creating distortions in markets in developed countries". This is entirely a separate issue from the promotion of research intended by the priority review program.
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The priority review voucher may tax FDA resources. To mitigate this, use of the priority review voucher includes an extra fee paid by manufacturers to the FDA and requires that voucher bearers provide FDA with 90 days' notice before using a voucher.
2980:
1194:
On a technical level, S. 2917 added "Filoviruses" to the priority review list. The Ebola virus is a type of Filovirus. According to the Congressional Budget Office, enactment of the law does not have an effect on the federal budget.
220:
The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. The provision applies to
1918:
156:, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a fee (approximately $ 2.8 million) to use the voucher.
1162:
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.
175:
to include rare pediatric diseases. The act built upon the tropical disease system and made amendments including a shorter notification to the FDA before exercising a voucher, a designation system so that early in the
1417:
Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.
2448:
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program will not slow the progress of other products awaiting FDA review. The cost has decreased dramatically from over $ 5 million in 2012. For the fiscal year 2018, this fee is $ 2.8 million.
1532:
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As of 2017, fourteen priority review vouchers have been awarded, four for tropical diseases, and ten for rare pediatric diseases. The first priority review voucher was awarded in 2009 to
1974:
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program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for disease indications with limited profitability.
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completing a priority review is six months. Priority review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses.
205:
alter the scientific/medical standard for approval or the quality of evidence necessary. Safety requirements for a priority review are equal to that of a standard review.
2741:
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world can have faster access to lifesaving products that may not otherwise be developed. And sponsors of neglected disease drugs can be rewarded for their innovations
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193:(PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
2026:
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1787:"FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality"
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2787:
2617:
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the United States for such rare pediatric disease product, and the actual amount of such rare pediatric disease product distributed in the United States.
2436:
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2642:
1662:
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229:(BLAs) and 505(b)(2) applications. The voucher, which is transferable and can be sold, entitles the bearer to a priority review for another product.
1159:
awarded, the Comptroller General of the United States is to conduct a study on the effectiveness of the pediatric priority review voucher program.
2686:
1676:
1439:
Critics of the FDA allege that priority review might not be safe. Priority review should not, however, be confused with accelerated approval or
2612:
1907:"First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response"
3181:
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2000:
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141:(FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The
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1504:
1479:
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3019:
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2711:
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had won for a recent rare disease drug approval for $ 67.5 million; the voucher cut four months off the regulatory review time for
1182:
In December 2014, the Senate approved a bill that would add the Ebola virus to the Priority Review Voucher List. The bill, S. 2917—
1174:
reauthorized the program until December 31, 2016 and instructed the GAO to compile a report on the effectiveness of the program.
55:
1268:
for $ 350 million. In 2016–2018, the value of a voucher ranged from $ 125 million to $ 200 million, down from its peak in 2015.
1061:
189:
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the
102:
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2761:
2701:
2122:
1204:
drugs to "prevent or treat harm from a biological, chemical, radiological or nuclear agent identified as a material threat".
703:
244:
Companies may also sell vouchers to other drug companies. Thus far, priority review vouchers have sold for $ 50–350 million.
226:
190:
148:
Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating
59:
74:
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3012:
2844:
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1912:
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1512:
613:
209:
138:
81:
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1083:
509:
149:
2242:"Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases"
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2970:
2839:
2567:
1261:
1233:
1056:
677:
88:
1171:
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554:
412:
3109:
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2609:, a critique from the WHO's Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)
1342:
1112:
720:
574:
454:
348:
70:
48:
2174:
1975:"FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation"
1135:
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3129:
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847:
2081:
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used when a drug does not fit these requirements, but the company wishes to expedite the review process.
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1066:
534:
326:
2596:
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2107:
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1088:
785:
514:
222:
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typically determine when drugs will be submitted until the results of safety studies are available.
3043:
3035:
2894:
1336:
1224:
596:
390:
370:
2057:"Section 529 Rare Pediatric Disease Priority Review Voucher Incentive Program, Public Law 112-144"
2874:
2869:
2549:
2319:
2292:"Preserving an Incentive for Global Health R&D: The Priority Review Voucher Secondary Market"
2269:
1637:
1373:
1130:
725:
660:
407:
2148:
1423:
radiological/nuclear material, a naturally occurring emerging disease, or a natural disaster."
2859:
2541:
2503:
2311:
2261:
1656:
1612:
745:
168:
2524:
Nardinelli C, Lanthier M, Temple R (July 2008). "Drug-review deadlines and safety problems".
999:
95:
3081:
2929:
2904:
2864:
2799:
2533:
2493:
2303:
2253:
1817:"FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs"
1602:
1592:
492:
343:
177:
3114:
2919:
2834:
1731:"FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia"
1390:
1045:
944:
927:
765:
466:
429:
1191:
an unlimited number of times and be used after a 90-day notification period to the FDA.
3124:
3119:
3104:
2939:
2914:
2909:
2884:
2849:
1379:
1321:
1309:
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969:
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591:
17:
2257:
3170:
2949:
2934:
2889:
2662:
2553:
2467:
2368:"Sanofi, Regeneron pay $ 67M for a shortcut in the blockbuster PCSK9 race with Amgen"
2201:"S. 2917, Adding Ebola to the FDA Priority Review Voucher Program Act; Cost Estimate"
1396:
1353:
1018:
365:
2273:
1847:"FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox"
1757:"First FDA-approved vaccine for the prevention of dengue disease in endemic regions"
1691:"Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2017"
3150:
3061:
2981:
Regulation of food and dietary supplements by the U.S. Food and Drug Administration
2944:
2323:
1401:
1327:
1315:
1287:
822:
635:
586:
153:
2027:"FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia"
1556:
1347:
1332:
1303:
1265:
1007:
907:
402:
360:
37:
1456:
1411:
1245:
1187:
1078:
980:
899:
693:
640:
504:
2403:
United Therapeutics Sells Priority-Review Voucher to AbbVie for $ 350 Million
2307:
1597:
1580:
3071:
2572:
2291:
2227:"Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs"
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1026:
879:
859:
805:
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715:
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382:
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2108:"Text - S.1878 - 114th Congress (2015-2016): Advancing Hope Act of 2016"
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1368:
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1298:
919:
839:
777:
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546:
424:
338:
318:
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266:
3004:
1607:
1705:"Issuance of Priority Review Voucher; Rare Pediatric Disease Product"
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1237:
1101:
961:
887:
867:
817:
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1249:
737:
2466:
This article incorporates text from this source, which is in the
1252:
to market with the first approval of a PCSK9 inhibitor. In 2015,
1505:"Expedited Programs for Serious Conditions––Drugs and Biologics"
1406:
1339:) (added in 2014 by Pub. L. 113-233, amended by Pub. L. 114-146)
3008:
2631:
2155:. Washington, D.C.: U.S. Library of Congress. December 16, 2014
31:
2342:"Drug Makers Buy Pricey Vouchers to Speed Products to Market"
2386:"Drug Firms Buy $ 67.5 Million Voucher to Speed FDA Review"
1950:"FDA Speeds Up Examination of 5 Drugs with Priority Review"
1877:"FDA approves new breakthrough therapy for cystic fibrosis"
1184:
Adding Ebola to the FDA Priority Review Voucher Program Act
2001:"FDA Approves First Drug to Treat Rare Metabolic Disorder"
167:
created the priority review voucher program for neglected
1468:
Bill Gates at the World Economic Forum in Davos in 2008.
985:
MET exon 14 skipping mutated non-small cell lung cancer
2607:
Optional Rewards for New Drugs for Developing Countries
2123:"Senators praise passage of faster Ebola review by FDA"
1533:"Regulatory Affairs Professionals Society | RAPS"
1276:
The eligible tropical diseases include the following:
1264:
sold a PRV for a drug for a rare pediatric disease to
173:
Food and Drug Administration Safety and Innovation Act
2420:
Jazz grabs Spark's priority review voucher for $ 110M
1677:"Priority Review Voucher Fees to Decline in FY 2017"
3143:
3090:
3042:
2958:
2822:
2806:
2794:
2782:
2775:
2734:
2669:
2593:
published by one of the Duke authors of the voucher
1260:for around $ 245 million, and later the same year,
165:
Food and Drug Administration Amendments Act of 2007
62:. Unsourced material may be challenged and removed.
27:
US Food and Drug Administration drug review program
2568:"Bill Gates - Bill & Melinda Gates Foundation"
2437:"Tropical Disease Priority Review Voucher Program"
2788:Title 21 of the Code of Federal Regulations (CFR)
2742:Family Smoking Prevention and Tobacco Control Act
2717:Office of Global Regulatory Operations and Policy
2175:"Cosponsors: S.2917 — 113th Congress (2013-2014)"
1551:
1549:
2618:Rare Pediatric Disease Priority Review Vouchers
2519:
2517:
1461:
1023:RET fusion-positive non-small cell lung cancer
269:. The next voucher was not awarded until 2012.
3187:Pharmaceutical regulation in the United States
2613:SEC. 524. (21 USC §360n) Text of the amendment
2480:Carpenter D, Zucker EJ, Avorn J (March 2008).
2149:"Summary: S.2917 — 113th Congress (2013-2014)"
1208:Proposed adoption by European Medicines Agency
273:Vouchers have been awarded for the following:
208:The amendment can be found on page 150 of the
3020:
2966:Criticism of the Food and Drug Administration
2643:
2181:. U.S. Library of Congress. December 16, 2014
8:
2692:Center for Food Safety and Applied Nutrition
2677:Center for Biologics Evaluation and Research
2384:Ron Winslow; Joseph Walker (July 30, 2014),
2285:
2283:
2976:History of the Food and Drug Administration
2812:Title 21 of the United States Code (U.S.C.)
2482:"Drug-review deadlines and safety problems"
2335:
2333:
1944:
1942:
1940:
1938:
1936:
1581:"Developing drugs for developing countries"
3027:
3013:
3005:
2779:
2707:National Center for Toxicological Research
2682:Center for Devices and Radiological Health
2650:
2636:
2628:
1527:
1525:
1523:
2497:
1606:
1596:
122:Learn how and when to remove this message
2240:Ridley DB, Sánchez AC (September 2010).
1579:Ridley DB, Grabowski HG, Moe JL (2006).
271:
2687:Center for Drug Evaluation and Research
1496:
1248:and was part of their strategy to beat
704:Medicines Development for Global Health
2597:"FDA to aid tropical disease research"
2451:from the original on December 20, 2019
2296:American Journal of Law & Medicine
1921:from the original on December 20, 2019
1661:: CS1 maint: archived copy as title (
1654:
1199:Extension for medical countermeasures
7:
2752:Federal Food, Drug, and Cosmetic Act
2106:Casey, Robert (September 30, 2016).
1152:Extension to rare pediatric diseases
802:Haemophagocytic lymphohistiocytosis
60:adding citations to reliable sources
1857:(Press release). September 24, 2019
257:Uses of the priority review program
171:. This was extended in 2012 by the
2340:Loftus, Peter (November 1, 2015).
2007:(Press release). November 23, 2020
1480:FDA Fast Track Development Program
1414:(added in 2016 by Pub. L. 114-146)
323:Multi-drug-resistant tuberculosis
137:is a program of the United States
25:
2712:Office of Criminal Investigations
2005:U.S. Food and Drug Administration
1979:U.S. Food and Drug Administration
1887:(Press release). October 21, 2019
1735:U.S. Food and Drug Administration
471:Lysosomal acid lipase deficiency
2725:
2461:
2290:Andrew S. Robertson (May 2016).
2121:Daw, Daniel (December 5, 2014).
2037:(Press release). October 8, 2021
1827:(Press release). August 14, 2019
657:RPE65-mutated retinal dystrophy
36:
1062:Chronic myelomonocytic leukemia
916:Material threat countermeasure
734:Material threat countermeasure
227:Biological License Applications
216:Priority review voucher program
47:needs additional citations for
2994:Commissioner of Food and Drugs
2776:Title 21 regulations and rules
2762:Prescription Drug User Fee Act
2702:Center for Veterinary Medicine
2532:(1): 95–6, author reply 96–8.
2366:John Carroll (July 30, 2014),
636:Mucopolysaccharidosis type VII
191:Prescription Drug User Fee Act
1:
2757:Food Safety Modernization Act
2258:10.1016/S0140-6736(10)60669-1
1797:(Press release). May 24, 2019
1343:Human African trypanosomiasis
3182:Food and Drug Administration
2659:Food and Drug Administration
2622:Food and Drug Administration
2591:Priority review voucher page
2443:Food and Drug Administration
2033:Food and Drug Administration
1913:Food and Drug Administration
1883:Food and Drug Administration
1853:Food and Drug Administration
1823:Food and Drug Administration
1793:Food and Drug Administration
1767:(Press release). May 1, 2019
1763:Food and Drug Administration
1565:Food and Drug Administration
1513:Food and Drug Administration
1186:, was introduced by Senator
551:Duchenne muscular dystrophy
210:Food and Drug Administration
139:Food and Drug Administration
2697:Center for Tobacco Products
2205:Congressional Budget Office
1387:(added in 2018 final order)
1350:(added in 2018 final order)
1312:(added in 2018 final order)
1306:(added in 2018 final order)
1084:Duchenne muscular dystrophy
1057:Cedazuridine and decitabine
510:Duchenne muscular dystrophy
150:neglected tropical diseases
3203:
2062:. Public Law. July 9, 2012
1318:/dengue haemorrhagic fever
1172:Advancing Hope Act of 2016
3110:African sleeping sickness
2989:
2971:FDA Most Wanted Fugitives
2747:Modernization Act of 1997
2723:
1304:Chikungunya virus disease
1262:United Therapeutics Corp.
1234:Regeneron Pharmaceuticals
782:Adenosine deaminase-SCID
678:X-linked hypophosphatemia
413:Asklepion Pharmaceuticals
163:In 2007, Title XI of the
2308:10.1177/0098858816658278
1598:10.1377/hlthaff.25.2.313
1178:Extension to ebola virus
884:Spinal muscular atrophy
844:F508del cystic fibrosis
555:Marathon Pharmaceuticals
531:Spinal muscular atrophy
212:Amendments Act of 2007.
3156:Priority review voucher
1310:Cryptococcal meningitis
1113:Alnylam Pharmaceuticals
721:Lennox-Gastaut syndrome
575:BioMarin Pharmaceutical
455:Alexion Pharmaceuticals
349:BioMarin Pharmaceutical
335:Rare pediatric disease
154:rare pediatric diseases
143:priority review voucher
18:Priority Review Voucher
2767:Pure Food and Drug Act
1471:
1441:fast track designation
950:Vertex Pharmaceuticals
848:Vertex Pharmaceuticals
2925:Andrew von Eschenbach
2800:Federal Register (FR)
2499:10.1056/NEJMsa0706341
1917:. December 19, 2019.
1693:. September 30, 2016.
1643:on September 10, 2008
1585:Health Aff (Millwood)
1324:(guinea-worm disease)
1240:purchased a PRV that
1136:Enzyvant Therapeutics
1107:Primary hyperoxaluria
1067:Astex Pharmaceuticals
1004:Mantle cell lymphoma
535:Ionis Pharmaceuticals
435:Wellstat Therapeutics
327:Janssen Pharmaceutica
223:New Drug Applications
2880:Alexander M. Schmidt
2082:"Public Law 112-144"
1485:Breakthrough therapy
1364:Lymphatic filariasis
1089:Sarepta Therapeutics
786:Leadiant Biosciences
515:Sarepta Therapeutics
265:for its approval of
56:improve this article
3044:Diseases of poverty
3036:Diseases of poverty
2959:Society and culture
2895:Arthur H. Hayes Jr.
2855:Charles W. Crawford
2538:10.1056/NEJMc086158
2447:. August 23, 2018.
2407:Wall Street Journal
2390:Wall Street Journal
2346:Wall Street Journal
2207:. November 25, 2014
2129:. Chicago, Illinois
1711:. December 13, 2018
1337:Ebola virus disease
1225:Wall Street Journal
1038:elantamab mafodotin
489:Cholera prevention
391:United Therapeutics
371:Knight Therapeutics
274:
3092:Neglected diseases
3077:Diarrheal diseases
2875:Charles C. Edwards
2845:Walter G. Campbell
2783:Administrative law
2409:(August 19, 2015).
1412:Zika virus disease
1374:Neurocysticercosis
1333:Filovirus diseases
1131:Congenital athymia
726:GW Pharmaceuticals
661:Spark Therapeutics
408:Zellweger syndrome
272:
3177:Tropical diseases
3164:
3163:
3002:
3001:
2860:George P. Larrick
2840:Charles A. Browne
2818:
2817:
2426:(April 30, 2018).
2401:Chelsey Dulaney,
1516:. April 10, 2019.
1451:News and reaction
1395:Soil-transmitted
1272:Diseases targeted
1144:
1143:
1042:Multiple myeloma
958:Tropical disease
896:Tropical disease
856:Tropical disease
814:Tropical disease
754:Tropical disease
746:SIGA Technologies
690:Tropical disease
583:Tropical disease
481:Tropical disease
451:Hypophosphatasia
357:Tropical disease
315:Tropical disease
295:Tropical disease
169:tropical diseases
132:
131:
124:
106:
71:"Priority review"
16:(Redirected from
3194:
3029:
3022:
3015:
3006:
2930:Margaret Hamburg
2905:David A. Kessler
2865:James L. Goddard
2780:
2729:
2728:
2652:
2645:
2638:
2629:
2578:
2577:
2564:
2558:
2557:
2521:
2512:
2511:
2501:
2477:
2471:
2465:
2464:
2460:
2458:
2456:
2433:
2427:
2416:
2410:
2399:
2393:
2392:
2381:
2375:
2374:
2363:
2357:
2356:
2354:
2352:
2337:
2328:
2327:
2302:(2–3): 524–542.
2287:
2278:
2277:
2237:
2231:
2230:
2223:
2217:
2216:
2214:
2212:
2197:
2191:
2190:
2188:
2186:
2171:
2165:
2164:
2162:
2160:
2145:
2139:
2138:
2136:
2134:
2118:
2112:
2111:
2103:
2097:
2096:
2094:
2092:
2078:
2072:
2071:
2069:
2067:
2061:
2053:
2047:
2046:
2044:
2042:
2023:
2017:
2016:
2014:
2012:
1997:
1991:
1990:
1988:
1986:
1981:. March 24, 2020
1971:
1965:
1964:
1962:
1960:
1946:
1931:
1930:
1928:
1926:
1903:
1897:
1896:
1894:
1892:
1873:
1867:
1866:
1864:
1862:
1843:
1837:
1836:
1834:
1832:
1813:
1807:
1806:
1804:
1802:
1783:
1777:
1776:
1774:
1772:
1753:
1747:
1746:
1744:
1742:
1737:. March 24, 2020
1727:
1721:
1720:
1718:
1716:
1709:Federal Register
1701:
1695:
1694:
1687:
1681:
1680:
1673:
1667:
1666:
1660:
1652:
1650:
1648:
1642:
1636:. Archived from
1635:
1627:
1621:
1620:
1610:
1600:
1576:
1570:
1569:
1561:
1553:
1544:
1543:
1541:
1539:
1529:
1518:
1517:
1509:
1501:
1469:
1217:Secondary market
344:Morquio syndrome
275:
178:drug development
127:
120:
116:
113:
107:
105:
64:
40:
32:
21:
3202:
3201:
3197:
3196:
3195:
3193:
3192:
3191:
3167:
3166:
3165:
3160:
3139:
3125:River blindness
3115:Schistosomiasis
3086:
3038:
3033:
3003:
2998:
2985:
2954:
2920:Lester Crawford
2835:Carl L. Alsberg
2830:Harvey W. Wiley
2814:
2802:
2795:Federal journal
2790:
2771:
2730:
2726:
2721:
2665:
2656:
2601:Financial Times
2587:
2582:
2581:
2566:
2565:
2561:
2526:N. Engl. J. Med
2523:
2522:
2515:
2492:(13): 1354–61.
2486:N. Engl. J. Med
2479:
2478:
2474:
2462:
2454:
2452:
2435:
2434:
2430:
2417:
2413:
2400:
2396:
2383:
2382:
2378:
2365:
2364:
2360:
2350:
2348:
2339:
2338:
2331:
2289:
2288:
2281:
2252:(9744): 922–7.
2239:
2238:
2234:
2225:
2224:
2220:
2210:
2208:
2199:
2198:
2194:
2184:
2182:
2173:
2172:
2168:
2158:
2156:
2147:
2146:
2142:
2132:
2130:
2120:
2119:
2115:
2105:
2104:
2100:
2090:
2088:
2080:
2079:
2075:
2065:
2063:
2059:
2055:
2054:
2050:
2040:
2038:
2025:
2024:
2020:
2010:
2008:
1999:
1998:
1994:
1984:
1982:
1973:
1972:
1968:
1958:
1956:
1948:
1947:
1934:
1924:
1922:
1905:
1904:
1900:
1890:
1888:
1875:
1874:
1870:
1860:
1858:
1845:
1844:
1840:
1830:
1828:
1815:
1814:
1810:
1800:
1798:
1785:
1784:
1780:
1770:
1768:
1755:
1754:
1750:
1740:
1738:
1729:
1728:
1724:
1714:
1712:
1703:
1702:
1698:
1689:
1688:
1684:
1675:
1674:
1670:
1653:
1646:
1644:
1640:
1633:
1631:"Archived copy"
1629:
1628:
1624:
1578:
1577:
1573:
1559:
1555:
1554:
1547:
1537:
1535:
1531:
1530:
1521:
1507:
1503:
1502:
1498:
1493:
1476:
1470:
1467:
1453:
1429:
1420:
1391:Schistosomiasis
1376:(added in 2015)
1295:(added in 2015)
1274:
1219:
1210:
1201:
1180:
1154:
1149:
1122:Rare pediatric
1098:Rare pediatric
1075:Rare pediatric
1046:GlaxoSmithKline
970:Merck & Co.
945:Cystic fibrosis
936:Rare pediatric
928:Bavarian Nordic
876:Rare pediatric
836:Rare pediatric
794:Rare pediatric
774:Rare pediatric
766:GlaxoSmithKline
712:Rare pediatric
669:Rare pediatric
649:Rare pediatric
627:Rare pediatric
605:Rare pediatric
571:Batten disease
563:Rare pediatric
543:Rare pediatric
523:Rare pediatric
501:Rare pediatric
463:Rare pediatric
443:Rare pediatric
430:Orotic aciduria
421:Rare pediatric
399:Rare pediatric
379:Rare pediatric
259:
250:
218:
187:
185:Priority review
135:Priority review
128:
117:
111:
108:
65:
63:
53:
41:
28:
23:
22:
15:
12:
11:
5:
3200:
3198:
3190:
3189:
3184:
3179:
3169:
3168:
3162:
3161:
3159:
3158:
3153:
3147:
3145:
3141:
3140:
3138:
3137:
3132:
3127:
3122:
3120:Dracunculiasis
3117:
3112:
3107:
3105:Chagas disease
3102:
3096:
3094:
3088:
3087:
3085:
3084:
3079:
3074:
3069:
3064:
3059:
3054:
3048:
3046:
3040:
3039:
3034:
3032:
3031:
3024:
3017:
3009:
3000:
2999:
2997:
2996:
2990:
2987:
2986:
2984:
2983:
2978:
2973:
2968:
2962:
2960:
2956:
2955:
2953:
2952:
2947:
2942:
2940:Scott Gottlieb
2937:
2932:
2927:
2922:
2917:
2915:Mark McClellan
2912:
2910:Jane E. Henney
2907:
2902:
2900:Frank E. Young
2897:
2892:
2887:
2885:Donald Kennedy
2882:
2877:
2872:
2870:Herbert L. Ley
2867:
2862:
2857:
2852:
2850:Paul B. Dunbar
2847:
2842:
2837:
2832:
2826:
2824:
2820:
2819:
2816:
2815:
2810:
2808:
2804:
2803:
2798:
2796:
2792:
2791:
2786:
2784:
2777:
2773:
2772:
2770:
2769:
2764:
2759:
2754:
2749:
2744:
2738:
2736:
2732:
2731:
2724:
2722:
2720:
2719:
2714:
2709:
2704:
2699:
2694:
2689:
2684:
2679:
2673:
2671:
2667:
2666:
2657:
2655:
2654:
2647:
2640:
2632:
2626:
2625:
2620:from the U.S.
2615:
2610:
2604:
2594:
2586:
2585:External links
2583:
2580:
2579:
2559:
2513:
2472:
2428:
2424:Fierce Biotech
2411:
2394:
2376:
2358:
2329:
2279:
2232:
2218:
2192:
2166:
2140:
2113:
2098:
2073:
2048:
2018:
1992:
1966:
1932:
1898:
1868:
1838:
1808:
1778:
1748:
1722:
1696:
1682:
1668:
1622:
1571:
1545:
1519:
1495:
1494:
1492:
1489:
1488:
1487:
1482:
1475:
1472:
1465:
1452:
1449:
1428:
1425:
1419:
1418:
1415:
1409:
1404:
1399:
1393:
1388:
1382:
1380:Onchocerciasis
1377:
1371:
1366:
1361:
1356:
1351:
1345:
1340:
1330:
1325:
1322:Dracunculiasis
1319:
1313:
1307:
1301:
1296:
1293:Chagas disease
1290:
1285:
1278:
1273:
1270:
1256:sold a PRV to
1218:
1215:
1209:
1206:
1200:
1197:
1179:
1176:
1153:
1150:
1148:
1145:
1142:
1141:
1138:
1133:
1128:
1123:
1119:
1118:
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1104:
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1086:
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1072:
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1064:
1059:
1054:
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1050:
1048:
1043:
1040:
1035:
1032:
1031:
1029:
1024:
1021:
1016:
1013:
1012:
1010:
1005:
1002:
997:
994:
993:
991:
986:
983:
978:
975:
974:
972:
967:
964:
959:
955:
954:
952:
947:
942:
937:
933:
932:
930:
925:
922:
917:
913:
912:
910:
905:
902:
897:
893:
892:
890:
885:
882:
877:
873:
872:
870:
865:
862:
857:
853:
852:
850:
845:
842:
837:
833:
832:
830:
825:
820:
815:
811:
810:
808:
803:
800:
795:
791:
790:
788:
783:
780:
775:
771:
770:
768:
763:
760:
755:
751:
750:
748:
743:
740:
735:
731:
730:
728:
723:
718:
713:
709:
708:
706:
701:
699:Onchocerciasis
696:
691:
687:
686:
683:
680:
675:
670:
666:
665:
663:
658:
655:
650:
646:
645:
643:
638:
633:
628:
624:
623:
621:
616:
611:
606:
602:
601:
599:
594:
592:Chagas disease
589:
584:
580:
579:
577:
572:
569:
564:
560:
559:
557:
552:
549:
544:
540:
539:
537:
532:
529:
524:
520:
519:
517:
512:
507:
502:
498:
497:
495:
490:
487:
482:
478:
477:
475:
472:
469:
464:
460:
459:
457:
452:
449:
444:
440:
439:
437:
432:
427:
422:
418:
417:
415:
410:
405:
400:
396:
395:
393:
388:
387:Neuroblastoma
385:
380:
376:
375:
373:
368:
363:
358:
354:
353:
351:
346:
341:
336:
332:
331:
329:
324:
321:
316:
312:
311:
309:
304:
301:
296:
292:
291:
288:
285:
282:
279:
258:
255:
249:
246:
217:
214:
186:
183:
130:
129:
44:
42:
35:
26:
24:
14:
13:
10:
9:
6:
4:
3:
2:
3199:
3188:
3185:
3183:
3180:
3178:
3175:
3174:
3172:
3157:
3154:
3152:
3149:
3148:
3146:
3144:Miscellaneous
3142:
3136:
3133:
3131:
3130:Leishmaniasis
3128:
3126:
3123:
3121:
3118:
3116:
3113:
3111:
3108:
3106:
3103:
3101:
3098:
3097:
3095:
3093:
3089:
3083:
3080:
3078:
3075:
3073:
3070:
3068:
3065:
3063:
3060:
3058:
3055:
3053:
3050:
3049:
3047:
3045:
3041:
3037:
3030:
3025:
3023:
3018:
3016:
3011:
3010:
3007:
2995:
2992:
2991:
2988:
2982:
2979:
2977:
2974:
2972:
2969:
2967:
2964:
2963:
2961:
2957:
2951:
2950:Robert Califf
2948:
2946:
2943:
2941:
2938:
2936:
2935:Robert Califf
2933:
2931:
2928:
2926:
2923:
2921:
2918:
2916:
2913:
2911:
2908:
2906:
2903:
2901:
2898:
2896:
2893:
2891:
2890:Jere E. Goyan
2888:
2886:
2883:
2881:
2878:
2876:
2873:
2871:
2868:
2866:
2863:
2861:
2858:
2856:
2853:
2851:
2848:
2846:
2843:
2841:
2838:
2836:
2833:
2831:
2828:
2827:
2825:
2823:Commissioners
2821:
2813:
2809:
2805:
2801:
2797:
2793:
2789:
2785:
2781:
2778:
2774:
2768:
2765:
2763:
2760:
2758:
2755:
2753:
2750:
2748:
2745:
2743:
2740:
2739:
2737:
2733:
2718:
2715:
2713:
2710:
2708:
2705:
2703:
2700:
2698:
2695:
2693:
2690:
2688:
2685:
2683:
2680:
2678:
2675:
2674:
2672:
2668:
2664:
2663:United States
2660:
2653:
2648:
2646:
2641:
2639:
2634:
2633:
2630:
2623:
2619:
2616:
2614:
2611:
2608:
2605:
2602:
2598:
2595:
2592:
2589:
2588:
2584:
2575:
2574:
2569:
2563:
2560:
2555:
2551:
2547:
2543:
2539:
2535:
2531:
2527:
2520:
2518:
2514:
2509:
2505:
2500:
2495:
2491:
2487:
2483:
2476:
2473:
2469:
2468:public domain
2450:
2446:
2444:
2438:
2432:
2429:
2425:
2421:
2415:
2412:
2408:
2404:
2398:
2395:
2391:
2387:
2380:
2377:
2373:
2372:FierceBiotech
2369:
2362:
2359:
2347:
2343:
2336:
2334:
2330:
2325:
2321:
2317:
2313:
2309:
2305:
2301:
2297:
2293:
2286:
2284:
2280:
2275:
2271:
2267:
2263:
2259:
2255:
2251:
2247:
2243:
2236:
2233:
2228:
2222:
2219:
2206:
2202:
2196:
2193:
2180:
2176:
2170:
2167:
2154:
2150:
2144:
2141:
2128:
2124:
2117:
2114:
2109:
2102:
2099:
2087:
2083:
2077:
2074:
2058:
2052:
2049:
2036:
2034:
2028:
2022:
2019:
2006:
2002:
1996:
1993:
1980:
1976:
1970:
1967:
1955:
1951:
1945:
1943:
1941:
1939:
1937:
1933:
1920:
1916:
1914:
1908:
1902:
1899:
1886:
1884:
1878:
1872:
1869:
1856:
1854:
1848:
1842:
1839:
1826:
1824:
1818:
1812:
1809:
1796:
1794:
1788:
1782:
1779:
1766:
1764:
1758:
1752:
1749:
1736:
1732:
1726:
1723:
1710:
1706:
1700:
1697:
1692:
1686:
1683:
1678:
1672:
1669:
1664:
1658:
1639:
1632:
1626:
1623:
1618:
1614:
1609:
1604:
1599:
1594:
1591:(2): 313–24.
1590:
1586:
1582:
1575:
1572:
1567:
1566:
1558:
1552:
1550:
1546:
1534:
1528:
1526:
1524:
1520:
1515:
1514:
1506:
1500:
1497:
1490:
1486:
1483:
1481:
1478:
1477:
1473:
1464:
1460:
1458:
1455:According to
1450:
1448:
1444:
1442:
1437:
1433:
1426:
1424:
1416:
1413:
1410:
1408:
1405:
1403:
1400:
1398:
1397:helminthiasis
1394:
1392:
1389:
1386:
1383:
1381:
1378:
1375:
1372:
1370:
1367:
1365:
1362:
1360:
1357:
1355:
1354:Leishmaniasis
1352:
1349:
1346:
1344:
1341:
1338:
1334:
1331:
1329:
1326:
1323:
1320:
1317:
1314:
1311:
1308:
1305:
1302:
1300:
1297:
1294:
1291:
1289:
1286:
1284:
1280:
1279:
1277:
1271:
1269:
1267:
1263:
1259:
1255:
1251:
1247:
1243:
1239:
1235:
1230:
1227:
1226:
1216:
1214:
1207:
1205:
1198:
1196:
1192:
1189:
1185:
1177:
1175:
1173:
1168:
1164:
1160:
1156:
1151:
1146:
1139:
1137:
1134:
1132:
1129:
1127:
1124:
1121:
1120:
1116:
1114:
1111:
1108:
1105:
1103:
1100:
1097:
1096:
1092:
1090:
1087:
1085:
1082:
1080:
1077:
1074:
1073:
1070:
1068:
1065:
1063:
1060:
1058:
1055:
1053:
1052:
1049:
1047:
1044:
1041:
1039:
1036:
1034:
1033:
1030:
1028:
1025:
1022:
1020:
1019:Selpercatinib
1017:
1015:
1014:
1011:
1009:
1006:
1003:
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45:This article
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3155:
3151:Malnutrition
3062:Tuberculosis
2945:Stephen Hahn
2600:
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2455:December 19,
2453:. Retrieved
2440:
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2418:Conor Hale,
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2351:November 19,
2349:. Retrieved
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2209:. Retrieved
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2183:. Retrieved
2179:Congress.gov
2178:
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2157:. Retrieved
2153:Congress.gov
2152:
2143:
2131:. Retrieved
2127:BioPrepWatch
2126:
2116:
2101:
2091:December 14,
2089:. Retrieved
2085:
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2066:November 19,
2064:. Retrieved
2051:
2039:. Retrieved
2030:
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2009:. Retrieved
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1925:December 19,
1923:. Retrieved
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1891:November 17,
1889:. Retrieved
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1861:November 17,
1859:. Retrieved
1850:
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1831:November 17,
1829:. Retrieved
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1801:November 17,
1799:. Retrieved
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1771:November 17,
1769:. Retrieved
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1739:. Retrieved
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1671:
1645:. Retrieved
1638:the original
1625:
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1538:December 14,
1536:. Retrieved
1511:
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1402:Tuberculosis
1328:Fascioliasis
1288:Buruli ulcer
1275:
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1229:for a drug.
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823:Fascioliasis
587:benznidazole
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54:Please help
49:verification
46:
29:
2807:Federal law
2624:(FDA), 2019
1959:November 6,
1557:"H.R. 3580"
1427:Limitations
1348:Lassa fever
1335:(including
1266:AbbVie Inc.
1008:Kite Pharma
908:TB Alliance
682:Ultragenyx
284:Indication
3171:Categories
2735:Major acts
2041:October 8,
2011:October 8,
1985:October 8,
1741:October 8,
1608:10161/7017
1491:References
1457:Bill Gates
1246:alirocumab
1188:Tom Harkin
1147:Extensions
1079:Vyondys 53
981:Capmatinib
900:Pretomanid
694:Moxidectin
641:Ultragenyx
505:Exondys 51
82:newspapers
3072:Pneumonia
2670:Divisions
2573:Microsoft
2554:205041656
2211:March 23,
2185:March 23,
2159:March 23,
2133:March 23,
1715:March 28,
1647:March 21,
1281:Blinding
1254:Retrophin
1232:In 2014,
1027:Eli Lilly
924:Smallpox
880:Zolgensma
860:Dengvaxia
806:Novimmune
758:Krintafel
742:Smallpox
716:Epidiolex
3135:Trachoma
2546:18596282
2508:18367738
2449:Archived
2316:29086641
2274:34391520
2266:20833303
1954:BioSpace
1919:Archived
1657:cite web
1617:16522573
1474:See also
1466:—
1283:trachoma
1242:BioMarin
1126:Rethymic
989:Novartis
940:Trikafta
828:Novartis
798:Gamifant
762:Malaria
673:Crysvita
653:Luxturna
631:Mepsevii
619:Novartis
567:Brineura
527:Spinraza
485:Vaxchora
474:Alexion
447:Strensiq
383:Unituxin
361:Impavido
307:Novartis
303:Malaria
287:Company
278:Program
263:Novartis
225:(NDAs),
3100:Cholera
3067:Measles
3057:Malaria
2661:of the
2603:in 2008
2599:at the
2324:3985989
2086:gpo.gov
1369:Malaria
1359:Leprosy
1299:Cholera
1109:type 1
1000:KTE-X19
920:Jynneos
864:Dengue
840:Symdeko
778:Revcovi
609:Kymriah
547:Emflaza
425:Xuriden
403:Cholbam
339:Vimizim
319:Sirturo
299:Coartem
267:Coartem
96:scholar
3082:Plague
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2544:
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2314:
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2246:Lancet
1615:
1385:Rabies
1316:Dengue
1258:Sanofi
1238:Sanofi
1102:Oxlumo
966:Ebola
962:Ervebo
888:AveXis
868:Sanofi
818:Egaten
493:PaxVax
467:Kanuma
98:
91:
84:
77:
69:
2550:S2CID
2445:(FDA)
2441:U.S.
2320:S2CID
2270:S2CID
2060:(PDF)
2035:(FDA)
2031:U.S.
1915:(FDA)
1911:U.S.
1885:(FDA)
1881:U.S.
1855:(FDA)
1851:U.S.
1825:(FDA)
1821:U.S.
1795:(FDA)
1791:U.S.
1765:(FDA)
1761:U.S.
1641:(PDF)
1634:(PDF)
1560:(PDF)
1508:(PDF)
1250:Amgen
1140:2021
1117:2020
1093:2020
738:Tpoxx
685:2020
614:B-ALL
290:Year
281:Drug
103:JSTOR
89:books
3052:AIDS
2542:PMID
2504:PMID
2457:2019
2353:2015
2312:PMID
2262:PMID
2213:2015
2187:2015
2161:2015
2135:2015
2093:2023
2068:2015
2043:2021
2013:2021
1987:2021
1961:2020
1927:2019
1893:2019
1863:2019
1833:2019
1803:2019
1773:2019
1743:2021
1717:2019
1663:link
1649:2008
1613:PMID
1540:2023
1407:Yaws
1236:and
1170:The
248:Cost
75:news
2534:doi
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2494:doi
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