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Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill

 
• By Derrick Gingery

PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.

drug ingredient
Generic drug sponsors would know whether their inactive ingredient guesses are right sooner under a provision in the House FDA user fee reauthorization bill. • Source: Shutterstock

Generic drug sponsors would receive more inactive ingredient information about their reference products faster thanks to a provision in the House US Food and Drug Administration user fee reauthorization bill.

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