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Long title | A bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes. |
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Acronyms (colloquial) | FDAMA |
Enacted by | the 105th United States Congress |
Effective | November 21, 1997 |
Citations | |
Public law | 105-115 |
Statutes at Large | 111 U.S. Stat 2296 |
Codification | |
Acts amended | Federal Food, Drug and Cosmetic Act |
Titles amended | Title 21 USC 301: Food and Drugs |
Legislative history | |
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The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol.