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.
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.