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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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.
Agency is pledging to act well ahead of the six-month review deadline in reviewing full applications for COVID 19 vaccines that are already authorized for emergency use. Going too fast may be counterproductive, in more ways than one.
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.