According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

The user fees model is offered within Euna Payments Cashiering module, which provides agencies with a secure, flexible platform to manage in-person payments and implement user fee models with ...

Euna Solutions®, a leading provider of purpose-built, cloud-based solutions for the public sector, today announced the introduction of user fee models on the Euna Payments Cashiering solution ...

If the FDA charged food companies user fees it could strengthen its oversight of food safety, according to a recent study. The study, “Advancing the FDA’s ...

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel uncertainty.

Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD, have been placed on administrative leave. The moves led to a 31% ...

A Bitcoin user accidentally paid $60,000 in transaction fees due to a replace-by-fee (RBF) mistake. Learn what RBF is and how to avoid losing money in crypto transactions.

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

PTC Therapeutics’ sepiapterin (formerly known as PTC923) is under FDA review for the treatment of paediatric and adult patients with PKU, with a Prescription Drug User Fee Act (PDUFA) target ...

Flutter calls Illinois betting fee disappointing as FanDuel adds $0.50 per bet charge starting September 2025 to offset costs.

Therefore, it seems notable that, as FDA and industry prepare to begin negotiations for the next user fee agreement, these documents are among the first substantive new guidance documents that FDA ...