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FDA Ends ANDA 'Reviews' To Streamline Approval Process

 
• By Derrick Gingery

Instead, US agency will conduct 'assessments' of generic drug applications, according to new MaPP.

FDA entrance sign 2016

The US FDA will "assess," rather than "review," generic drug applications going forward as part of a larger effort to streamline their evaluations and increase competition in the market.

In a new Manual of Policy and Procedures document released Jan. 3, the agency said it will refer to ANDA evaluations as assessments and called reviewers assessors to promote...

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More from Biosimilars & Generics

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• By Derrick Gingery

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