FDA Announces 2022 Public Meeting and Comment Period on Reauthorization of Animal Drug User Fee Program

November 25, 2022 — 

The U.S. Food and Drug Administration will hold a public meeting on December 7, 2022, to offer opportunity for comment on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA). 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 gives the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug review process. The FDA's responsibility is to ensure these drugs are safe and effective and these resources enhance the timeliness and predictability of application review for animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $32 million in user fees, supplementing budget authority funding, for the new animal drug program. The user fee program expires on September 30, 2023.

Read more and register at FDA.

[Source: FDA 18 November 2022]