Public Law 97-414

E642118

Public Law 97-414 is the U.S. federal statute commonly known as the Orphan Drug Act of 1983, which incentivizes the development of treatments for rare diseases through benefits such as market exclusivity and tax credits.

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Label Occurrences
Public Law 97-414 canonical 1

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Statements (47)

Predicate Object
instanceOf Orphan Drug Act ⓘ
United States federal statute ⓘ
administeredBy Office of Orphan Products Development ⓘ
U.S. Food and Drug Administration ⓘ
alsoKnownAs Orphan Drug Act of 1983 ⓘ
amends Federal Food, Drug, and Cosmetic Act ⓘ
appliesTo biological products for rare diseases ⓘ
drugs for rare diseases ⓘ
beneficiary drug sponsors developing orphan drugs ⓘ
patients with rare diseases ⓘ
congressNumber 97th United States Congress ⓘ
country United States ⓘ
dateSigned 1983-01-04 ⓘ
definesTerm orphan drug ⓘ
rare disease ⓘ
effect financial incentives for sponsors of orphan drugs ⓘ
increased number of approved orphan drugs ⓘ
eligibilityCriterion disease affecting fewer than 200,000 persons in the United States ⓘ
no reasonable expectation of recovering development costs from U.S. sales ⓘ
enactedBy United States Congress ⓘ
establishes orphan drug designation process ⓘ
hasComponent orphan drug market exclusivity provision ⓘ
orphan drug tax credit ⓘ
orphan product grants program ⓘ
historicalContext early 1980s concern about lack of treatments for rare diseases ⓘ
inForce true ⓘ
legalCitation 96 Stat. 2049 ⓘ
marketExclusivityDuration 7 years ⓘ
officeOfSigner President of the United States ⓘ
policyArea health law ⓘ
pharmaceutical regulation ⓘ
rare disease policy ⓘ
primaryPurpose to encourage development of drugs for rare diseases ⓘ
to provide incentives for orphan drug development ⓘ
providesIncentive grant funding for clinical research ⓘ
market exclusivity ⓘ
tax credits for clinical testing ⓘ
waiver or reduction of FDA user fees ⓘ
publicLawNumber 97-414 ⓘ
regulatoryBody Center for Biologics Evaluation and Research ⓘ
Center for Drug Evaluation and Research ⓘ
sectorImpacted biotechnology industry ⓘ
pharmaceutical industry ⓘ
shortName Orphan Drug Act ⓘ
signedBy Ronald Reagan ⓘ
title An Act to amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes ⓘ
yearEnacted 1983 ⓘ

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Full triples — surface form annotated when it differs from this entity's canonical label.

Orphan Drug Act of 1983 → legalCitation → Public Law 97-414 ⓘ