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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 arise in an NDA and avoid slowing or stopping an approval, or as some have

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