I usually get a flu shot around this time each year and, in recent years, an updated COVID vaccine. I sit at my computer, go on my local retail pharmacy’s website, and select a date for my immunizations in the not-too-distant future so I’ll have adequate protection during that flu season. In addition, I’m convinced […]
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International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment.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: […]
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 […]
With the addition of the six new vouchers awarded today, the total number of CNPVs awarded is fifteen. It’s interesting to note that Dr. George Tidmarsh, the short-time CDER Director, was reported to have been critical of the CNPV program, worried that the compressed one to two month review and approval times would compromise safety and […]
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 […]
The Commissioner’s National Priority Voucher (CNPV) program is designed to shorten the review times of complete submitted New Drug Applications (NDAs) and Biologics License Applications (BLAs) from a standard ten months to two months. We have written previous blogs on this topic as can be seen here, here, and here and have expressed some concerns […]
The proposed legislation is welcomed by those in the biosimilar space and the FDA because for years the FDA has said that all biosimilar products, based on the current review and approval paradigm, should be considered interchangeable. The EU has adopted that position as well; however, this bill, if passed, will be the necessary legislative […]
FDA announced a new revised draft guidance which “is being updated and reissued in draft to, among other things, include the addition of information related to Congress’ 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This […]
Priority review vouchers are awarded to the sponsors of applications for tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) products that gain approval. The new fee for use of a priority review voucher is the same for each type of voucher as identified in the table below: The pre-publication Federal Register Notice […]
