The U.S. Food and Drug Administration will hold public meetings on May 20 to offer opportunity for discussion on the proposed reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The FDA is also providing the opportunity for the public to comment on the user fee programs and make suggestions regarding features that the FDA should propose for the next ADUFA and AGDUFA programs. Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below. [Source: FDA]
ADUFA and AGDUFA give the FDA the authority to collect user fees that provide funding to support the new animal drug and generic new animal drug review processes, respectively. These resources support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews. These programs expire on September 30, 2023. Without new legislation reauthorizing these programs, the FDA will no longer have the authority to collect user fees to help fund the new animal drug and generic new animal drug review processes.
Register for the virtual meeting by May 18 here.