In a very interesting decision, the United States District Court for the District of Columbia ruled that the FDA erred in not granting a pediatric rare disease voucher to Sun Pharmaceutical’s injectable phenobarbital drug for the treatment of a rare seizure disorder in pediatric patients less than four years of age. The Court cited statutory […]
The FDA has made clear that it is interested in hearing your thoughts on the OTC drugs approved through the NDA process and wants your feedback on a number of topics. In a pre-publication notice in the Federal Register yesterday (here), the FDA noted that it would like interested parties to “share their perspectives with […]
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 […]
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 […]
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 an announcement today, the FDA has explained its decision to revise the labeling of hormone replacement therapy (HRT) products based on reevaluation of older studies in light of new data. The FDA recognizes a difference between the risks associated with oral HRT products vs. vaginally applied HRT products and the labeling changes reflect this […]
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 […]
