Memo To US FDA: ‘Too Fast!’ Plus ‘Too Slow!’ Does Not Mean ‘Just Right!’
There is an old adage that FDA only has two speeds: too fast and too slow. Recent pushback on neurology reviews and Covid vaccines show that paradox – but also the flaw of treating contradictory criticism as a sign that everything is actually fine.
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Reforming Accelerated Approval: Three Ideas For Congress
Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.
Robert Califf’s Chance To Make History At The US FDA
Robert Califf’s first tenure as US FDA Commissioner was decidedly anti-climactic. His return trip – assuming the Senate confirms him – will be potentially transformational: he will be the leader that defines what FDA is after COVID.
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.