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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.

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