Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.
The user fee legislation that the Senate HELP Committee will markup on May 10 is mostly the bland, renewal-only document (a "clean" bill in legislative parlance) that circulated last month, but a manager's amendment released May 8 gives a sense of where senators, while not exactly getting their hands dirty, have decided to nudge FDA.
The additions have mostly avoided the controversial topics of the day, even as the bill now skirts the pricing debate...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
