The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
I usually write a little funny or fanciful poem at this time of year but what can we say about the first eleven months of 2025 that makes us want to even smile? Many longtime FDA friends and colleagues have left the Agency. The FDA has been under significant stress from RIFs, firings, and layoffs, […]
On November 24, 2025, the FDA announced (here) that, following a comprehensive safety review, it has approved a reformulated ranitidine tablet, “marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during […]
The process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted […]
This blog is another in a series providing an analysis of legislative initiatives that may impact your business. Q4 is the time of year when many pharmaceutical companies scan the horizon and develop their enterprise risk assessments and mitigation plans, which should trigger a review of these initiatives. The Economic Crime and Corporate Transparency Act […]
Even after he originally said that he wasn’t interested in the job, Richard Padzur, M.D., a long-time (26-year!) veteran of the FDA, was named Director of the Center for Drug Evaluation and Research. As the founding director of the FDA’s Oncology Center of Excellence and in his tenure leading the Oncology Division, Dr. Padzur has been […]
In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators […]
The AAM GRx+Biosims meeting was in progress when word came down that, within minutes, a new guidance document would be released by the FDA to outline conditions under which comparative efficacy studies (CES) may not be required for biosimilar applications. The draft Guidance for Industry (here) is titled Scientific Considerations in Demonstrating Biosimilarity to a […]
As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
Paul Schwartz was honored with the highest award given by the Association of Accessible Medicines, the lifetime achievement award. Paul came to the FDA two years after I started in 1984 and after his decades of service with the FDA, he recently retired from the Agency as the Director, Division of Postmarketing Assessment II, in […]
