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...
US FDA Drug Office Reform: 'Everything' Is On The Table
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.
Gottlieb Promotes 'Team' Work For Product Reviews
US FDA Commissioner intends to change agency's siloed structure and move reviewers into teams that will follow products pre- and post-market.
FDA's Oncology Center Of Excellence On Equal Terms With CDER In New Org Chart
While OCE has a lofty status, it has yet to gain a large cadre of staff.