PDUFA VI: Breakthrough Issues Among FDA Priorities
This article was originally published in The Pink Sheet Daily
Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.
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Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
Greater development and use of real-world evidence, such as pragmatic clinical trials and observational studies, to support regulatory decisions on drug efficacy are limited by regulatory, technical and practical hurdles, stakeholders say.
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.