PDUFA VI: Innovative Trial Design Talks Can’t Have Formal Meeting Goals, FDA Says
This article was originally published in The Pink Sheet Daily
FDA tells industry that proposal on trials also can’t use SPA-like process.
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Three-to-five year timeline needed to develop algorithms does not engender confidence that new version of formula, which historically pushed user fee rates higher, will be ready before PDUFA VII begins.
User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.
In addition to user fees, upcoming FDA reviews will also focus on oversight of post-marketing requirements and information exchange in the drug supply chain.