Life Science Compliance Update



The 21st Century Cures Act Moves One Step Closer to Reality with FDA’s Work Plan

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

With the formal legislative passage of the 21st Century Cures Act (“Act”), a bipartisan effort to expedite research and development and approval of new drugs, the U.S. Food and Drug Administration (“FDA”) is now moving full-steam ahead by making public its legislative implementation work plan in regard to the Act, including a list of agency policy objectives, list of deliverables, and a detailed summary of budget allocations for such Act. Although the FDA’s implementation efforts in this regard are still emerging, it is clear that the Agency is seeking in every way possible to make the Act a new reality for all stakeholders in the life sciences community.


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