summary
Introduced
05/15/2018
05/15/2018
In Committee
05/17/2018
05/17/2018
Crossed Over
06/20/2018
06/20/2018
Passed
Dead
12/31/2018
12/31/2018
Introduced Session
115th Congress
Bill Summary
Long-Term Opioid Efficacy Act of 2018
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to conduct post-approval studies on certain controlled substances, including drugs that are or contain a controlled substance, to assess potential reductions in the drug's effectiveness. The bill establishes that the FDA can require such studies if it determines that new effectiveness information exists, in addition to the existing authority to require studies for new safety information. The bill also specifies that conducting these studies will not be considered a new clinical investigation for the purposes of exclusivity periods.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (4)
Last Action
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 06/20/2018)
Official Document
bill text
bill summary
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bill summary
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bill summary
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