ODA

E642116

ODA refers to the Orphan Drug Act of 1983, a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity and tax credits to drug manufacturers.

All labels observed (1)

Label Occurrences
ODA canonical 1

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf United States federal law
administeredBy FDA Office of Orphan Products Development NERFINISHED
U.S. Food and Drug Administration NERFINISHED
aimsTo incentivize development of orphan drugs
appliesTo biologics
drugs
rare diseases
beneficiary biotechnology companies
drug manufacturers
patients with rare diseases
country United States of America
surface form: United States
definesConcept orphan drug
rare disease
enactedBy United States Congress
encourages research and development for rare conditions
focusesOn unmet medical needs in small patient populations
hasAbbreviation ODA NERFINISHED
hasEffect increases number of approved treatments for rare diseases
reduces financial risk of orphan drug development
hasProvision clinical research tax credit
market exclusivity period for designated drugs
orphan drug designation process
user fee exemptions for designated products
influenced orphan drug legislation in other countries
jurisdiction United States government
surface form: United States federal government
language English
legalStatus in force
policyGoal improve access to treatments for rare diseases
stimulate private investment in orphan drug development
providesIncentive fee waivers
grant funding
market exclusivity
tax credits
purpose to encourage development of drugs for rare diseases
regulates orphan drugs
relatedTo U.S. Food and Drug Administration NERFINISHED
rare disease advocacy groups
sector healthcare
pharmaceutical industry
shortName ODA NERFINISHED
signedBy Ronald Reagan
subjectArea health law
pharmaceutical regulation
rare disease policy
typeOfIncentiveLaw innovation incentive law
yearEnacted 1983

How these facts were elicited

Referenced by (1)

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