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ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

 
• By Derrick Gingery

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.

FDA entrance sign 2016

Pre-submission meetings with the US FDA are popular among complex generic sponsors, but there are questions about how best to make them part of the product development process, since it appears even companies are having trouble fitting them into their schedules.

"A current challenge is how industry will integrate product development and pre-submission meetings into a product development timeline," according the...

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