FDA Schedules Third Animal Drug Fee Conference
Published Date: 6/3/2026
Notice
Summary
The FDA is hosting its Third Annual Animal Drug User Fee Educational Conference on July 7, 2026, to help drug makers and animal health experts understand the new animal drug approval process. This free event is both in-person and online, making it easy to join. Stakeholders should register early and can send feedback within 90 days after the meeting to help shape future policies and fees.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
User Fees Authorized Through 2028
The Animal Drug User Fee Amendments of 2023 (ADUFA V) authorize FDA to collect user fees for certain new animal drug applications, products, establishments, and sponsors through fiscal year 2028. These fees supplement FDA funding for drug review activities.
Free FDA Animal Drug Training
The FDA is holding a free public educational conference on July 7, 2026, from 9 a.m. to 1 p.m. ET to help animal drug makers, veterinary professionals, and other stakeholders understand the new animal drug approval process. The event is available both in person and online so attendees can join either way.
90-Day Comment Opportunity
After the conference, stakeholders may submit comments to the docket within 90 days to request topics or provide feedback that can shape future agency policies and user fees. Comments submitted electronically to Regulations.gov will be posted publicly unless submitted as confidential paper copies following FDA instructions.
In-Person Access Rules and Deadlines
If you attend in person, you must be REAL ID compliant to enter the federal building and should register online no later than June 25, 2026. Virtual registration remains open until the conference starts, giving a remote option for those who cannot meet in-person requirements.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11060 — Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability
The FDA just released a revised draft guide to help drug and device makers share important cost and coverage info with insurance companies and similar groups. This update clears up how to talk about approved products, unapproved products, and new uses, making it easier for everyone to understand the rules. Companies should send their feedback by August 3, 2026, so the FDA can finalize the guide—potentially speeding up coverage decisions and saving money.
2026-11062 — Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
The FDA is officially pulling the plug on 16 generic drug approvals because the companies told them these medicines aren’t being sold anymore. This change kicks in on July 6, 2026, and it won’t stop companies from trying again later if they want. If you’re a drug maker or just curious, this means fewer old approvals cluttering the books and a cleaner, fresher drug list.
2026-11054 — Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability
The FDA just dropped a draft guide to help companies making gene therapy products that use genome editing. It shows how to use what’s already known to speed up development and get safer, smarter treatments to patients faster. If you’re in this field, send your feedback by September 1, 2026, so your voice shapes the final rules—saving time and money down the road!
2026-10904 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
The FDA is officially putting the new swallowed device for constipation into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this cool innovation by cutting down red tape. The new rules took effect June 1, 2026, and could save companies time and money getting their devices approved.
2026-10908 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
The FDA is officially classifying rigid sterilization containers with electronic monitoring as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change helps hospitals and medical device makers get these safer, smarter containers to patients faster and easier. The new rules took effect June 1, 2026, making it simpler and potentially less costly to bring these devices to market.
2026-10873 — Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability
The FDA is rolling out a new draft guide to help cancer drug makers speed up safety testing for biologic and conjugated medicines. This plan cuts down on extra animal testing and uses smarter methods learned during the COVID-19 pandemic. Drug developers should send their feedback by July 31, 2026, to shape the final rules and save time and money in bringing new cancer treatments to patients.
Previous / Next Documents
Previous: 2026-11100 — Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Bank companies want to grow by forming new groups, buying other banks, or merging with them. If you’re involved with these companies, you can share your thoughts by July 3, 2026. These moves could change who controls local banks and might affect money and services in your community.
Next: 2026-11103 — Notice Announcing School Safety Enhancement Program Competition
The Department of Education and Health and Human Services are inviting states to apply for grants to make schools safer in 2026. These grants will help improve school security, emergency plans, and training for staff and officers, especially focusing on lessons from past school tragedies. Applications are due by July 28, 2026, so states should act fast to secure funding and protect their students.