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FDA Says It’s The Law, Denies Petition Requesting GDUFA Fee Payment Changes

 
• By Derrick Gingery

The agency also says only Congress could enact fee waivers and exemptions, but Square Pharmaceuticals indicates it will join lobbying efforts to create them.

FDA encouraged a generic manufacturer that political action is the only way it can affect changes to the GDUFA fee payment schedule, not through the citizen petition process.

The agency denied a citizen petition from Square Pharmaceuticals Ltd. that asked the agency to charge a company’s generic drug...

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More from North America

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