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Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed

 
• By Derrick Gingery

US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.

Gottlieb meets Alexander
Sen. Lamar Alexander meets with FDA Commissioner nominee Dr. Scott Gottlieb in Alexander’s Washington, D.C., office. A confirmation hearing is expected to be scheduled once the HELP Committee receives Gottlieb's Office of Government Ethics paperwork. • Source: Courtesy of Sen. Alexander’s office

FDA commissioner nominee Scott Gottlieb could fuse staff specialization ideas in the 21st Century Cures bill and user fee reauthorization to create a more modular personnel grouping of reviewers.

The idea could allow specialists in certain clinical or product issues to be accessed by reviewers or divisions when they...

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