1. Pink Sheet

US FDA Inspection Goals Reduced After Shutdown; Review Dates Look Safe

 
• By Michael McCaughan

Commissioner Gottlieb tells Congress that FDA won’t meet all its planned goals for inspections after month-long partial government shutdown, but he does not expect a noticeable impact on product reviews. The longer term impact will depend on morale: hiring and retention are key focus. 

Concept of missed target business strategy. Worker diagnosis the untargeted arrow on dart board
US FDA is going to miss its inspection targets after the partial government shutdown.

The US FDA is reducing its target for the number of medical product inspections it will conduct during fiscal 2019 as a result of the 35-day partial government shutdown at the start of the year.

“We’re lowering our inspectional and import and field sampling goals for the year,” Commissioner Scott Gottlieb told the House Appropriations/Agriculture...

More from Manufacturing

More from Compliance