Research ReportCRS ReportVersion 3
R46110
Defining Active Ingredient: The U.S. Food and Drug Administration’s Legal Interpretation of Regulatory Exclusivities
Published Aug 8, 2023Updated Jun 21, 2025
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The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.
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Protecting Access to Safe and Effective Medicines Act of 2019
Nov 1, 2019 · Referred to the Subcommittee on Health.
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- S 1895116th Congress
Lower Health Care Costs Act
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- S 415117th Congress
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Apr 23, 2021 · Became Public Law No: 117-9.