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Biosimilars
Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks begin on reauthorizing the scheme for another five years. BsUFA, which funds FDA’s biosimilar reviews through user fees, expires in September 2027 and will require new legislation to continue. 7 January 2026
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Latest News & Features of interest to FDA
Biosimilars
Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks begin on reauthorizing the scheme for another five years. BsUFA, which funds FDA’s biosimilar reviews through user fees, expires in September 2027 and will require new legislation to continue. 7 January 2026
Pharmaceutical
Across major agencies, the past fortnight brought a steady cadence of regulatory decisions, committee opinions, and implementation guidance, rather than a single dominant theme. The European Medicines Agency (EMA) led the week’s visible outputs, with its human medicines committee publishing a dense set of recommendations. 17 December 2025
Pharmaceutical
Several regulators have released updates in recent days, ranging from drug approvals to procedural changes. A few approvals stood out for rare conditions, while other notices dealt with inspection policies, transparency measures, or emerging technology guidance. The pace of decisions remains steady but uneven, reflecting routine end-of-year activity. 10 November 2025
Pharmaceutical
George Tidmarsh has resigned as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) after being placed on administrative leave late last week. 4 November 2025
Pharmaceutical
In the last week on the regulatory front, the European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), completed its 27-30 October session and decided to issue a targeted professional communication on injectable forms of tranexamic acid, signalling increased risk-management attention across the EU. 3 November 2025
Biotechnology
The biologics supply chain has shifted from a technical backwater into a political and regulatory battleground. Vectors, plasmids, and the raw materials that feed them are now viewed as strategic assets. The combination of geopolitical pressure, pandemic scars, and new GMP scrutiny has sparked a wave of capacity building, supplier diversification, and make-versus-buy soul-searching across the USA and Europe. 18 September 2025
Pharmaceutical
Global regulators have kept busy over the past two weeks, with fresh approvals in oncology and rare disease as well as new safety actions. The FDA cleared its first intravesical gemcitabine system for bladder cancer and broadened use of selumetinib to younger children with neurofibromatosis. 15 September 2025
Pharmaceutical
On Friday, the US Food and Drug Administration revealed it has established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the US market. 6 September 2025
Pharmaceutical
The US regulator has rolled out a new pathway aimed at smoothing development for medicines targeting very small patient populations. The Rare Disease Evidence Principles (RDEP), unveiled Wednesday, outline a process that allows drugs and biologics for severe, genetically defined conditions with fewer than 1,000 US patients to be cleared on the basis of one well-controlled trial plus supporting confirmatory evidence. 4 September 2025
Pharmaceutical
For decades, advisory committees have been a cornerstone of US drug regulation. These panels of outside experts were designed to provide credibility, transparency, and independence in decisions that shape medicine. But recent moves, political shifts, and controversial approvals raise a blunt question: how much influence do they really have left? 3 September 2025
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