BioCentury
ARTICLE | Politics & Policy

Partial shutdown sees 41% of FDA staff furloughed

December 22, 2018 5:26 AM UTC

FDA has furloughed almost half its staff after the U.S. government partially shut down early Dec. 22, potentially slowing approvals and stalling advisory committee meetings.

Commissioner Scott Gottlieb confirmed in a tweet Friday that FDA cannot accept NDAs or other new regulatory submissions during the shutdown. The agency will not have authority to collect FY19 user fee payments for PDUFA, GDUFA and BsUFA and other user fee programs while it waits for an FY19 appropriation or continuing resolution to be enacted, according to FDA's website...