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Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs

 
• By Derrick Gingery

If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.

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Allowing bridging of US and foreign reference standards could lower generic drug development costs, the industry argues. • Source: Shutterstock

Generic industry sponsors want the US Food and Drug Administration to consider researching whether foreign reference products could be used to show bioequivalence in the US.

Not only would such a move likely streamline generic drug approvals in the US, but also could help alleviate ongoing problems with sponsors

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