United States · Bill · S
S. 658 (116th)
ADAPT Act
Introduced
5 March 2019
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
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Subjects
Discovery layer
Source updated
21 April 2025
Summary
Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act This bill authorizes the Food and Drug Administration (FDA) to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug. The FDA must process and review an application under this bill within 180 days of submission.
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 5 March 2019
Introduced in Senate (PDF)
Introduced in Senate · EN · 5 March 2019
Introduced in Senate
summary · EN · 5 March 2019
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/116th-congress/senate-bill/658
- Open data entity: https://api.congress.gov/v3/bill/116/s/658