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

FDA counsel Brian Malkin discussed the recent language change in the internal FDA policy manual in an article published by Pink Sheet titled, “In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?”

The FDA recently began using the phrasing “abbreviated new drug application (ANDA) assessments” instead of “ANDA reviews.” The implications of this modified language has been debated. Some argue that the change marks a definitive shift in the FDA’s approach to drug approval, while others argue the change means very little. Brian contributed to the discussion by noting, “A review is more of an evaluation of the application to determine whether it has met the criteria for approval, while an assessment targets the application components.” To read the article in full, click here (subscription required). 

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