EMA, FDA To Address Quality Issues For PRIME/Breakthrough Designation Products
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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Regulators, Industry Agree That Frequent Communication Is Key In Developing Breakthrough, PRIME Therapies
EU and US FDA regulators and industry share strategies for expediting the development of breakthrough and PRIME therapies.
Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.