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Wednesday, February 27, 2013
February 27, 2013 FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment - See more at: http://www.policymed.com/2013/02/fda-strategic-plan-to-address-drug-shortages-solicitation-for-comment.html#sthash.RZdGQEmp.dpuf
Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding ideas stakeholders and the public may have for combating drug shortages. As noted on FDA’s own blog, the agency believes that despite the progress made over the last year, even more can be done and is therefore turning to the American public for advice.
Comments due by Thursday, March 14, 2013. The Docket Number is FDA-2013-N-0124.
Background
As we previously wrote this summer, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) on July 9, 2012. Section 1003 of FDASIA adds section 506D to the Federal Food, Drug, and Cosmetic Act (the FDCA) to require the formation of a task force to develop and implement a strategic plan for enhancing the Agency's response to preventing and mitigating drug shortages. Section 506D of the
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