EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products

31 Jul 2018
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

Experience with early access schemes in the EU and the US – i.e., PRIME and breakthrough therapy designation – has shown that sponsors face challenges in complying with quality and manufacturing data requirements.

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EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products

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