Statements (57)
Predicate | Object |
---|---|
gptkbp:instanceOf |
gptkb:United_States_federal_law
|
gptkbp:amends |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
multiple times |
gptkbp:appliesTo |
generic pharmaceuticals
brand-name pharmaceuticals |
gptkbp:associated_with |
generic drug manufacturers
brand-name drug manufacturers the pharmaceutical supply chain |
gptkbp:challenges |
in courts
|
gptkbp:enactedBy |
gptkb:United_States_Congress
|
gptkbp:encourages |
research and development in pharmaceuticals
|
gptkbp:facilitates |
abbreviated new drug applications (ANDAs)
|
gptkbp:has_a_focus_on |
healthcare_reform_discussions
|
gptkbp:has_implications_for |
patient access to medications
drug innovation |
gptkbp:hasConflictWith |
over patent validity
|
https://www.w3.org/2000/01/rdf-schema#label |
Hatch-Waxman Act
|
gptkbp:impact |
pharmaceutical industry
pharmaceutical patent strategies |
gptkbp:influenced |
international drug policy discussions
|
gptkbp:influences |
drug pricing
|
gptkbp:involves |
patent litigation provisions
|
gptkbp:is_a_key_component_of |
the_U.S._drug_approval_system
|
gptkbp:is_a_model_for |
other countries' drug laws
|
gptkbp:is_a_subject_of |
public policy debates
academic research legislative review political scrutiny legal analysis |
gptkbp:is_essential_for |
public health
generic drug approval. |
gptkbp:is_involved_in |
trade agreements
|
gptkbp:is_linked_to |
drug safety regulations
|
gptkbp:is_part_of |
U.S._healthcare_policy
the_U.S._legal_framework_for_pharmaceuticals |
gptkbp:is_referenced_in |
healthcare_policy_debates
|
gptkbp:is_studied_in |
economic studies of drug markets
|
gptkbp:is_used_in |
congressional hearings
legal cases regarding drug patents pharmaceutical law courses |
gptkbp:landmark |
legislation in drug policy
|
gptkbp:led_to |
increased availability of generic drugs
|
gptkbp:mandates |
patent term extensions
|
gptkbp:operates_in |
gptkb:Food_and_Drug_Administration_(FDA)
|
gptkbp:previousName |
Drug Price Competition and Patent Term Restoration Act
|
gptkbp:promotes |
competition in drug market
|
gptkbp:provides |
market exclusivity for brand-name drugs
|
gptkbp:purpose |
to encourage the development of generic drugs
|
gptkbp:reduces |
time for generic drug approval
|
gptkbp:related_to |
intellectual property law
biologics regulation drug approval processes pharmaceutical regulation |
gptkbp:was_a_factor_in |
drug patent expirations
generic drug pricing strategies |
gptkbp:was_a_response_to |
high drug prices
|
gptkbp:yearEstablished |
1984
|