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ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'

 
• By Derrick Gingery

FDA is again relying on sponsor self-reporting as it launches GDUFA II.

FDA again will by relying on industry prior to GDUFA II's launch to ensure new user fees are correct. In this case, it's the ANDA holder fee, which was created for the reauthorization of the Generic Drug User Fee Act in part to provide a break for small businesses. It is based on the number of approved ANDAs a sponsor and its affiliates own.

To ensure FDA has the most accurate information on ANDA owners and their affiliates, the agency plans to publish its...

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