1. Pink Sheet

US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee

 
• By Derrick Gingery

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.

CDER Director Patrizia Cavazzoni answers questions virtually on drug development in neurodegenerative diseases during a House Energy and Commerce Health Subcommittee hearing. • Source: Screenshot

Rather than creating another expedited pathway, Patrizia Cavazzoni suggested to members of Congress that the key to speeding development in neurodegenerative diseases is a better scientific understanding of the conditions.

During a 29 July House Energy and Commerce Health Subcommittee hearing on advancing treatments for neurodegenerative diseases, Chair Anna Eshoo, D-Calif., pitched establishing a conditional approval pathway similar to the system used in Europe

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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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