House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.
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The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.
A bipartisan letter from several key legislators is pushing the US FDA to match its actions to its rhetoric when it comes to the handling of ALS drug reviews. Amylyx’ pending AMX0035 isn’t mentioned but seems unavoidably the subject.
PhRMA is funding an initiative to establish a network of sustainable, community-based trial sites. During 18-month proof of concept phase, 10 sites will receive training, technical support and mentorship.