What does ADUFA mean in FDA
The Animal Drug User Fee Act (ADUFA) was enacted in 2003 to provide for the timely review of approved animal drugs within specific timelines by the Food and Drug Administration (FDA). It also creates fees that are paid to FDA by certain sponsors, including generic animal drug applicants, to cover regulatory activities associated with the review process.
ADUFA meaning in FDA in Governmental
ADUFA mostly used in an acronym FDA in Category Governmental that means Animal Drug User Fee Act of 2003
Shorthand: ADUFA,
Full Form: Animal Drug User Fee Act of 2003
For more information of "Animal Drug User Fee Act of 2003", see the section below.
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Essential Questions and Answers on Animal Drug User Fee Act of 2003 in "GOVERNMENTAL»FDA"
What is ADUFA?
ADUFA stands for Animal Drug User Fee Act which was a law passed in 2003 to authorize the collection of user fees from sponsors applying for approval of new animal drugs and supplements.
Who pays these user fees?
These user fees are paid by the sponsors of new animal drug applications, abbreviated new animal drug applications, and generic animal drug applications.
What types of activities does FDA use these fees for?
The ADUFA user fees are used to pay for FDA resources related to its evaluation and review of new animal drugs, substantial amendments or supplements, generic animal drug applications. These resources include salaries and expenses associated with pre-approval inspections and post-marketing requirements.
How often must sponsors submit an application under ADUFA?
Sponsors must submit an application at least once every two years.
Final Words:
The Animal Drug User Fee Act is an important piece of legislation that helps ensure timely review of approved animal drugs by providing dedicated funding for FDA staff involved in this process. This fee is paid by sponsors who have applied for approval or supplement a product already on the market, thus helping promote safer foods for animals and humans alike.