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Complex Generics May Need New Communications Options In GDUFA III

 
• By Derrick Gingery

US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.

Agreement business handshake partnership deal as a solution strategy with a team coming together out of tangled twisted roads on to a bridge to find a common goal.
The FDA and complex generic sponsors are looking for more opportunities to discuss scientific questions and potentially streamline the assessment process. • Source: Shutterstock

A new communications channel may on the agenda for the upcoming user fee negotiations to help complex generic sponsors deal with mid-assessment changes to their applications.

Robert Lionberger, director of the Office of Research and Standards in the US Food and Drug Administration's Office of Generic Drugs, said there is no "clear system set up for...

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