EMA, FDA to Address Quality Issues for PRIME/Breakthrough Designation Products

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. Register for our free email digests: Source: Shutterstock

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.

Register for our free email digests:

Source: pink.pharmaintelligence.informa.com