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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.

The change is intended to speed generic entry, but the brand industry already is concerned, which could endanger its survival...

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