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US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

 
• By Derrick Gingery

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

FY13-FY17 Linkage of Research To Pre-ANDA Meetings
In some generic product categories where there were many FDA research projects, there also were several pre-ANDA meeting requests, suggesting the studies may have helped sponsors move forward with development. • Source: FDA presentation slides

It appears the US FDA may be able to influence generic drug sponsors' development priorities with its research projects, or at least pique their interest.

Data suggests that pre-ANDA meeting requests sometimes correlate with the number of internal and external research projects in the category, particularly when it comes to complex generics. Agency studies may...

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