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US FDA Still Fighting Problems With Pre-ANDA Meeting Requests

 
• By Derrick Gingery

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

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The FDA granted more pre-ANDA meetings for complex generics through the first nine months of FY 2019 than in all of FY 2018. • Source: Shutterstock

Complex generic product sponsors seem to have a better handle on the purpose of the US Food and Drug Administration's pre-ANDA meeting program but still are struggling with the requirements.

Data through the first three quarters of fiscal year 2019 suggest that sponsors are seeing fewer meeting requests denied because...

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