Shutdown Over, FDA to Take Triage Approach to Workload

Posted 18 October 2013 | By Alexander Gaffney, RAC 

The US government shutdown is over, and the US Food and Drug Administration's (FDA) thousands of furloughed staff members are returning to work. But don't expect the agency to be back to full capacity for a little while yet, FDA confirmed this week.

"Effective immediately, all FDA employees are reporting to work at their regular schedules," said Steven Immergut, assistant commissioner for media affairs at FDA, to Focus. "We are prioritizing our work appropriately as we transition back to normal operations."

Among the top priorities will be resuming routine domestic and international inspections of regulated facilities, he said.

In addition, the end of the shutdown brings good news for industry. Immergut noted that the agency will now be able to accept all medical product regulatory submissions for the 2014 Fiscal Year. During the shutdown, the agency was unable to accept any applications that had not paid a fee prior to 1 October 2013, leaving many drug, medical device, and biological applications in a holding pattern.

Now any applications under the Prescription Drug User Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act or the Biosimilar User Fee Act will be able to be accepted and processed.

"FDA is pleased that the government shutdown has ended and the agency can get back to fully resuming the important work that we do every day to protect and promote the public health," Immergut said.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles