US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee
CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.
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More Action, Less Plan? House Keeps Pressure On US FDA Over ALS Drugs
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.
The Yin And Yang Of Accelerated Approval Reform Proposals
The challenges to reforming the US FDA Accelerated Approval pathway are nicely illustrated by comparing the first two legislative proposals offered by the Democratic and Republican leadership. The bills are almost exactly opposite in intent – though perhaps there is some room for consensus on first steps.
US FDA Accelerated Approvals Could Expire Under New Legislation, But Big Loophole Included
The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.