Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed
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.
You may also be interested in...
Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.
US FDA Commissioner intends to change agency's siloed structure and move reviewers into teams that will follow products pre- and post-market.
While OCE has a lofty status, it has yet to gain a large cadre of staff.