![cover image](https://wikiwandv2-19431.kxcdn.com/_next/image?url=https://upload.wikimedia.org/wikipedia/commons/thumb/5/5c/Great_Seal_of_the_United_States_%2528obverse%2529.svg/640px-Great_Seal_of_the_United_States_%2528obverse%2529.svg.png&w=640&q=50)
Food and Drug Administration Safety and Innovation Act
Piece of American regulatory legislation / From Wikipedia, the free encyclopedia
Dear Wikiwand AI, let's keep it short by simply answering these key questions:
Can you list the top facts and stats about Food and Drug Administration Safety and Innovation Act?
Summarize this article for a 10 year old
SHOW ALL QUESTIONS
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.[1]
Quick Facts Long title, Enacted by ...
![]() | |
Long title | An Act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. |
---|---|
Enacted by | the 112th United States Congress |
Citations | |
Public law | Pub. L.Tooltip Public Law (United States) 112–144 (text) (PDF) |
Statutes at Large | 126 Stat. 993 through 126 Stat. 1132 (140 pages) |
Legislative history | |
|
Close