CDER Director’s Office May Take Over ‘Crisis’ Management of Drug Shortages

The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says. If the staff is elevated, it will report to CDER Deputy Director for Regulatory Programs Doug Throckmorton, according to an FDA memo distributed Thursday. The proposal comes as the FDA prepares to implement new shortage-response tools provided by the recently passed Food and Drug Administration Safety and Innovation Act.
Drug Industry Daily