9:26 PM
Dec 21, 2018
 |  BC Extra  |  Politics & Policy

Partial shutdown sees 41% of FDA staff furloughed

Editor's Note: This article was updated on Dec 28, 2018 at 11:24 AM PST

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.

Congress failed to reach a short- or long-term budget fix by Thursday, when it adjourned until Dec. 31.

Read the full 496 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

$50 USD
More Info >