Rare Pediatric Disease Priority Review Voucher
GPTKB entity
Statements (29)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA incentive program
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:awardedBy |
approval of drugs for rare pediatric diseases
|
| gptkbp:benefit |
entitles holder to priority review of another drug application
|
| gptkbp:criticizedFor |
may not always lead to new drug development
potential for windfall profits |
| gptkbp:eligibility |
applicant must request voucher upon submission
drug must not have been previously approved drug must treat a rare pediatric disease |
| gptkbp:fareControl |
yes
|
| gptkbp:feePurpose |
offset cost of expedited review
|
| gptkbp:firstAwarded |
2014
|
| https://www.w3.org/2000/01/rdf-schema#label |
Rare Pediatric Disease Priority Review Voucher
|
| gptkbp:introducedIn |
2012
|
| gptkbp:legalBasis |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
21 U.S.C. § 360ff |
| gptkbp:notableRecipient |
gptkb:BioMarin_Pharmaceutical
gptkb:Novartis gptkb:United_Therapeutics |
| gptkbp:purpose |
incentivize development of drugs for rare pediatric diseases
|
| gptkbp:relatedTo |
Priority Review Voucher
Tropical Disease Priority Review Voucher |
| gptkbp:reviewTimeReduction |
reduces FDA review time from 10 months to 6 months
|
| gptkbp:sells |
yes
|
| gptkbp:transferredTo |
yes
|
| gptkbp:validOn |
program periodically reauthorized by Congress
|
| gptkbp:市值 |
hundreds of millions of dollars
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|