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Generic Drugs Complete Response Letters Regulation

US FDA Wants To Predict ANDA Complete Response Responses

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Executive Summary

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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