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Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

16 December 2016

Focus on Regulation

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to publicly post their expanded access (EA) policies for individual patient access. This deadline falls on February 11, 2017. For new investigational drugs, this provision applies upon initiation of a Phase II or Phase III study for that drug.

Read More: Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

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