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Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation

 
• By Derrick Gingery

FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.

FDA likely will be just starting to count the generic drug manufacturer facilities eligible for its new user fee when the program launches, meaning the bulk of revenue likely will not begin arriving until a few months later.

The agency is required to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished...

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