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Food and Drug Administration Amendments Act of 2007; Long title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
2007: MDUFA II: FDA Amendments Act of 2007: Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA ...
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. Pub. L. 110–317 (text) August 29, 2008
Following the passing of the Act, there were calls for the FDA to publish a timeline for the implementation of the UDI; [6] this was subsequently done. [7] GUDID Submission The Final Rule on Unique Device Identifiers also mandates medical device manufacturers to make a submission to the FDA's Global Unique Device Identification Database.
The Sentinel System uses pre-existing electronic healthcare data (including billing data). Part of the Sentinel System is a tool called Active Postmarket Risk Identification and Analysis (ARIA) system that was mandated in the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007.
It was mandated by the Federal Food, Drug, and Cosmetic Act, [1] as modified by Food and Drug Administration Amendments Act of 2007 on 27 September 2007, and is the analogue of the New Drug Application for humans. [citation needed]
June 14, 2007: Preserving United States Attorney Independence Act of 2007, Pub. L. 110–34 (text), 121 Stat. 224 (including Fair Minimum Wage Act of 2007) July 26, 2007: Foreign Investment and National Security Act of 2007 , Pub. L. 110–49 (text) (PDF) , 121 Stat. 246
The 2007 Food and Drug Administration Amendments Act created section 505-1 of the Food, Drug, and Cosmetic Act which allowed for the creation of the REMS program for applying individual monitoring restrictions to medications. [5]