FDA Says Hepatitis Delta Is Not Tropical Enough
Published Date: 5/22/2026
Notice
Summary
The FDA decided not to add Hepatitis Delta Virus (HDV) to the list of tropical diseases because it doesn’t fully meet the rules about market size and who it affects. This means drug makers won’t get special priority review vouchers for HDV treatments right now. People working on HDV drugs should keep an eye out for future updates but won’t see changes or new incentives immediately.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
No Priority-Review Vouchers for HDV Now
On May 22, 2026, the FDA decided not to add Hepatitis Delta Virus (HDV) infection to the list of "tropical diseases" under Section 524 of the Federal Food, Drug, and Cosmetic Act. That means sponsors developing HDV prevention or treatment drugs are not eligible for tropical disease Priority Review Vouchers (PRVs) at this time, so they will not receive that special FDA priority-review incentive immediately.
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
2026-13047 — Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-13820 — Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that TOVALT ODT tablets (5 mg and 10 mg) weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions, making it easier and cheaper for people who need this sleep aid. If approved, more affordable options could hit the shelves soon, helping patients and saving money.
2026-13778 — Medical Device User Fee Amendments; Public Meeting; Request for Comments
The FDA is planning a public meeting on August 5, 2026, to talk about renewing fees that medical device makers pay to help speed up device reviews from 2028 to 2032. This affects companies making medical devices and could impact how much they pay and how fast their products get approved. The current fee program ends in September 2027, so the FDA wants your thoughts before finalizing new rules and fees.
2026-13716 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
The FDA just updated the rules for new animal drugs, approving several new and generic medicines for pets and farm animals from early 2026. These changes help keep animal treatments safe and effective, and the updates take effect right away on July 7, 2026. If you’re a drug maker or animal caretaker, these approvals and sponsor changes could impact what medicines are available and when.
2026-13534 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings
The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!
2026-13616 — Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications
The FDA is officially pulling the plug on 34 drug approvals because the companies stopped selling these medicines. This change kicks in on August 5, 2026, and it mainly affects drug makers like Endo Operations and Pfizer. No money penalties here—just a clean break, but companies can ask to reapply if they want to bring the drugs back.
Previous / Next Documents
Previous: 2026-10260 — Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Regional Coastal Observing Systems (RCOS)
NOAA is asking for approval to keep collecting info from 11 groups involved in Regional Coastal Observing Systems. They’re updating the program’s name and cutting down the paperwork time, but the info they collect stays the same. This helps improve ocean safety, protect the environment, and boost the economy, with a small time commitment of about 75 hours per response.
Next: 2026-10269 — Keystone Private Income Fund, et al.
Keystone Private Income Fund and its partners want permission to team up and invest together in the same companies, which usually isn’t allowed. This change affects several investment funds and could help them share opportunities and risks more easily. If no one objects by June 15, 2026, the SEC will likely approve this move, potentially opening doors for smarter, joint investments.