Search results
Results from the WOW.Com Content Network
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
This article incorporates public domain material from websites or documents of the Congressional Budget Office. [1]The Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 would authorize the collection and spending of fees by the Food and Drug Administration (FDA) for certain activities to expedite the development and marketing approval of drugs for use in animals.
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 Reauthorization Act of 2017
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.
Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013. Animal Drug User Fee Amendments of 2013 Animal Generic Drug User Fee Amendments of 2013 Authorizes collection and spending of fees by the Food and Drug Administration (FDA) for certain activities to expedite the development and marketing approval of drugs for use in animals
FDA Reauthorization Act of 2017: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. Pub. L. 115–52 (text) 115-53: August 22, 2017 Northern Mariana Islands Economic Expansion Act
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.