Aduhelm Invades Senate Committee’s COVID-19 Hearing
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.
You may also be interested in...
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.
In report language, the committee funds more CBER cell and gene therapy staff for rare diseases and suggests AI be considered to speed up complex generic assessments.
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.