Alzheimer’s Can Follow HIV And Become Chronic Condition If Science Advances, Woodcock Argues
The acting US FDA commissioner equates drug development in the neurodegenerative diseases to work on HIV.
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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.
Aduhelm Invades Senate Committee’s COVID-19 Hearing
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.
House Appropriations Committee Embraces Clinical Trial Issues In FY 2022 US FDA Budget Bill
Report language includes several mentions of improving trial diversity and recruitment, while bill offers a 5% increase in funding.