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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

New drug sponsors are increasingly interested in talking with US Food and Drug Administration officials about their development programs, making timely dates harder to find.

Agency officials did not meet any of their goals for on-time scheduling of formal meetings with sponsors in fiscal year 2017 and also did not expect to meet several of them in FY 2018, according to the FY 2018 prescription drug user fee program 

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