US Generic Reviews: Would Pre-Submission Meetings Be Better Than Six-Month Priority Review?

 
• By Derrick Gingery
  
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Lawmakers inquire about expanding pre-submission meetings to include non-complex priority ANDAs, suggesting it could be another way to help deal with drug pricing issues.

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Encouraging pre-submission meetings with the US FDA for some ANDA sponsors could become an alternative to requiring faster priority reviews in an effort to bring down drug prices. But the concept may suffer from some of the same problems that have led to industry and agency skepticism of legislative proposal for faster priority reviews – FDA doesn't have the resources, and swift review isn't the only component needed to have an abundance of generics on the market.

While it may not be possible to schedule meetings to address questions about every priority ANDA submitted, it could help...

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