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US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It

 
• By Derrick Gingery

Agency willing to talk to generic sponsors about complex product issues, but it can avoid the resource-intensive process by updating product-specific development guidances.

FDA entrance sign 2016

In creating opportunities for early interaction on complex generic product development, the US FDA may have excited sponsors, but at the same time the agency also gave itself an incentive to prevent the system's use.

Absent product-specific guidance on a complex generic or an alternative equivalence evaluation where a development guidance has been issued, agency officials must allow sponsors the pre-ANDA product development meeting.

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