Today, the FDA published a draft guidance titled Forms FDA 3542a and FDA 3542: Questions and Answers (here) that provides NDA sponsors with more information on patent submission than perhaps you ever even thought possible. The document identifies twenty-nine different questions and corresponding answers to clarify who needs to submit patent information, what patent information […]
In the Federal Register of March 3, 2026, the FDA published a request for information and comments on the Agency’s series of guidances for industry on Scale-Up and Post-Approval Changes (SUPAC) for specific dosage forms. Based on the requests received from interested parties, the FDA is reopening the comment period and extending it for an additional […]
In today’s prepublication of the Federal Register, the FDA, in response to an over-the-counter (OTC) monograph order request (OMOR), announced the availability of an amended final administrative order (OTC000039) for sunscreen ingredients permitting the over-the counter (OTC) use of the ingredient bemotrizinol, considering it to be generally recognized as safe and effective (GRASE) for its […]
The European Commission’s newly released draft guidelines (May 2026) on high-risk AI systems mark a pivotal step in operationalizing the EU AI Act. While the Act itself established a risk-based regulatory framework back in 2024, these guidelines provide much-needed clarity on how to determine whether an AI system falls into the “high-risk” category—arguably the most […]
On June 4th, the FDA issued a guidance document titled Certain Postapproval Requirements and Resources for ANDAs (here) in an effort to streamline ANDA approval letters. Previously, each ANDA approval letter had certain information regarding standard or specific post-approval requirements. Instead, the new guidance document provides a listing of the standard requirements and responsibilities of […]
As we noted in the May mid-month blog report (here), the May approval action total was likely to be much lower than April’s high for the fiscal year of 85 full and 19 tentative approval actions. Well, May’s numbers are indeed lower, and by quite a bit. The unofficial peek at the monthly figures in […]
In what these days appears to be highly unusual, a 9-0 ruling by the justices of the Supreme Court “overturned a lower court’s decision in favor of Amarin. Generic drugmakers argued that a ruling in favor of Amarin in the case would have discouraged them from making and selling their lower-cost drugs and increased U.S. […]
On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]
Over the last week, the FDA issued a series of seven warnings about supplements that contain undeclared drugs. Six of the products contain numerous undeclared active drug ingredients including the usual suspects sildenafil, tadalafil, and testosterone propionate on the erectile dysfunction side of the house and piroxicam for relieving pain/arthritis. The seventh product, Tawon Liar, […]
In case you didn’t get the message when the FDA issued FY 2026 OMUFA facility user fee invoices a few weeks ago (on April 20, 2026), you’d better act fast as those fees are due today (see the FDA notice here). If you’ve already paid your OMUFA facility fee, the Agency thanks you; if not or “[i]f […]
