US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

 
• By Derrick Gingery

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

Hands
FDA officials and assessors increasingly cannot attend formal meetings within the stated goal because of scheduling problems, according to the FY 2018 PDUFA performance report. • Source: Shutterstock

More from Review Pathways

More from Pathways & Standards