21 U.S.C. § 360bb et seq.

GPTKB entity

Statements (17)
Predicate Object
gptkbp:instanceOf gptkb:United_States_federal_law
gptkbp:administeredBy gptkb:U.S._Food_and_Drug_Administration
gptkbp:alsoKnownAs gptkb:Orphan_Drug_Act
gptkbp:citation gptkb:21_U.S.C._§_360bb_et_seq.
gptkbp:criteria disease affecting fewer than 200,000 people in the U.S.
gptkbp:dateEnacted 1983
gptkbp:defines orphan drug
gptkbp:enactedBy gptkb:United_States_Congress
https://www.w3.org/2000/01/rdf-schema#label 21 U.S.C. § 360bb et seq.
gptkbp:partOf gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:provides grant funding for research
incentives for orphan drug development
market exclusivity for 7 years
tax credits for clinical testing
gptkbp:purpose to encourage development of drugs for rare diseases
gptkbp:bfsParent gptkb:Orphan_Drug_Act_of_1983
gptkbp:bfsLayer 7