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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.
This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. [1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. [2]
The U.S. legislation was signed by Bill Clinton on 21 November 1997, [2] and fully enacted by 1 April 1999, [3] putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutical drugs. [4]
This is a chronological list of United States federal legislation passed by the 107th and subsequent United States Congresses, starting in 2001. It includes links to articles on major legislation. For comprehensive lists, see the lists of acts passed by each Congress. For the main article on this subject, see List of United States federal ...
(The Center Square) – A bipartisan group of lawmakers has introduced bicameral legislation to help reduce the “prevalence and severity” of prescription drug shortages. The End Drug Shortages ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices. The 2016 21st Century Cures Act codified into law the expedited regulatory review for devices granted breakthrough device designation and clarified how certain categories of medical software can and ...
A woman accusing renowned cage fighter Conor McGregor of raping her in a civil lawsuit in Ireland was found "very bruised" immediately after the alleged attack, a paramedic who treated her has ...