FDA Fixes Blunder: One Generic Drug Stays on Shelves

2026-09767 — Oscar Bobo: Final Debarment Order

Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He ignored the chance to defend himself, so the ban started on May 15, 2026. This means no drug imports from him for a while, but he can apply to end the ban anytime if he meets FDA’s conditions.

2026-09448 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3

The FDA is asking for approval to collect info for the third group in its Real Cost Campaign, which teaches kids about the dangers of tobacco. This helps the FDA improve its anti-smoking messages and protect young people’s health. Comments on this info collection are open until June 12, 2026, with no new costs for participants.

2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

The FDA wants your thoughts on how drug companies report problems after their products hit the market. This affects drug makers and healthcare folks who keep track of side effects. They’re asking for comments by July 13, 2026, to help improve the process without adding extra costs or paperwork.

2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.

The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If approved, the renewal keeps these products on the market with their modified risk status, affecting smokers and the tobacco industry starting May 13, 2026.

2026-09335 — Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection

Hey there! This update is all about a new medical device that helps doctors quickly find germs and their resistance traits in people who might have bone infections. It affects hospitals and labs by officially classifying this device, making it easier and faster to diagnose tough infections. The change kicks in soon, helping patients get the right treatment without delay—and it could save money by avoiding wrong meds!

2026-09368 — Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability

The FDA is setting clear rules for certain new tobacco products like e-cigarettes and nicotine pouches that don’t have official approval yet. Companies selling these products without permission might face enforcement actions starting now, so they need to get authorized or risk penalties. This helps protect public health and keeps the market fair and safe.

Previous: 2026-05912 — Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

SpecGx LLC wants to become a big-time maker of some powerful and tightly controlled drugs, including things like psilocybin and fentanyl. People and companies already registered can share their thoughts or ask for a hearing by May 26, 2026. This move could shake up how these substances are made and handled, so keep an eye on the deadlines if you’re involved!

Next: 2026-05914 — Notice Pursuant to the National Cooperative Research and Production Act of 1993-Pistoia Alliance, Inc.

The Pistoia Alliance, a group working together on science and tech projects, just updated its membership by adding six new members and saying goodbye to two. These changes keep the group’s special legal protections in place, helping members avoid big lawsuits over their teamwork. If you’re involved or interested, keep an eye out because membership stays open and updates will keep coming!