FDA Announces 2017 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Program

The U.S. Food and Drug Administration will hold public meetings to offer opportunity for discussion on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The recommendations will be published and posted online when available, prior to the meeting on November 2, 2017. Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below. 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, 2018. Without new legislation reauthorizing these programs, 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.