US FDA Wants To Predict ANDA Complete Response Responses

Generic industry, FDA discuss potential ways to increase transparency so agency can better estimate when – and even whether – an ANDA receiving a complete response will be returned.

FDA entrance sign 2016

Just as industry wants more certainty built into the generic drug assessments, the US FDA wants more certainty about industry's role, namely when or if sponsors will deal with issues identified in complete response letters.

Industry and agency officials discussed "possible ways to increase industry transparency in its intended response timelines" after an ANDA complete...

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