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International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment.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: […]
Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]
The newly issued revised and finalized “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry” (here) does not differ much from the previous draft guidance of the same title issued on April 25, 2024 (89 FR 31757). The final guidance was revised to incorporate comments […]
The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]
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 […]
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 […]
On day two of AAM’s October meeting, a panel including Jim Polli, Ph.D., Professor at the University of Maryland, Anna Scwenderman, Ph.D., Professor at the University of Michigan College of Pharmacy, and Aaron Josephson, Senior Director at Teva Pharmaceuticals, discussed the International Generic and Biosimilar Medicines Association’s (IGBA) project update on Single Global Development for […]
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 […]
Secretary Kennedy has basically accused much of the FDA and other parts of the HHS organization of being corrupt. One of his stated goals was to root out corruption. However, he never explicitly defined what the corruption was or identified any individual accused of it. Instead, he spoke of the revolving door where FDA employees […]
