FDA Awards Fast-Track Voucher for Rare Kids' Blood Disorder Drug

2026-12167 — Andrew Jonathan Morgan: Final Debarment Order

Andrew Jonathan Morgan is officially banned for 5 years from importing any drugs into the U.S. because he was convicted of a serious crime related to drug importation. He didn’t respond to the FDA’s notice, so the ban started on June 17, 2026, and he can apply to end it anytime. This means no drug imports from him for a while, keeping things safe and legal.

2026-12165 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule

The FDA is officially putting the ingestible gastrointestinal blood detection capsule into Class II, meaning it now has special safety rules but fewer hurdles than before. This change helps patients get access to this cool, innovative device faster and keeps it safe and effective. The new classification is effective June 17, 2026, and could save time and money for makers and users alike.

2026-12166 — Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan

The FDA is officially putting radiology software that uses machine learning and has a set plan for updates into a safer, easier-to-manage category called Class II. This change helps make sure the software is safe and effective while speeding up patient access to cool new tech. It’s been effective since early 2023, so companies can expect fewer hoops to jump through without extra costs or delays.

2026-11966 — Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

The FDA just dropped a draft guide to help businesses fill out Forms FDA 3542a and FDA 3542 without confusion. If you submit these forms, this guide answers your top questions and makes the process smoother. You’ve got until August 14, 2026, to send in your feedback before the FDA finalizes the guide—no extra costs, just clearer steps!

2026-11998 — Amendment and Revocation of Organizational Information Regulations

The FDA is updating its rules to point everyone to its website for the latest contact and organizational info, ditching old, unnecessary regulations. This makes it easier for the public to find accurate info all in one place, starting June 15, 2026. If you interact with the FDA, expect smoother access with no extra costs or delays.

2026-11760 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods

The FDA is asking for approval to collect extra records from food businesses that handle certain high-risk foods. This helps track food sources quickly to keep everyone safe. Food companies should get ready to keep and share these new records, and comments on this plan are due by July 13, 2026.

Previous: 2026-03492 — Petition for Exemption; Summary of Petition Received; Morningside University

Morningside University has asked the FAA for a special exemption from some aviation rules. This could affect students and staff involved in their aviation programs by changing how certain regulations apply. People have until March 16, 2026, to share their thoughts, and no extra costs or delays are expected right now.

Next: 2026-03495 — Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The FDA has decided that Klonopin tablets in 0.125 mg and 0.25 mg strengths were not taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their versions of these Klonopin tablets, as long as they meet all other rules. Patients and pharmacies could see more affordable options soon, with no safety worries holding things back.