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In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?

 
• By Derrick Gingery

MaPP revision may be just a better description of ANDA evaluations – or indicative of a broad culture change, experts tell the Pink Sheet.

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The US FDA's decision to change ANDA "reviews" to "assessments" may represent a sea change in its approach to generic drug reviews. Or it could simply be a more accurate description of the increasingly complicated application evaluation system. Opinions of the significance of the new wording, which was recently rolled out in an internal FDA policy manual, appear to stretch the gamut.

Attorney Kurt Karst, director at Hyman, Phelps and McNamara, said in an interview with the Pink Sheet that it is only a terminology change. He said the agency now is emphasizing how ANDA evaluations always have been assessments

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