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The FDA’s Action Plan Demands Some Industry Action, Too

It may take years to iron out some wrinkles, but it’ll be worth it

Patrick Stone
Mon, 05/04/2015 - 13:13
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The U.S. Food and Drug Administration (FDA) has a “Plain Jane” version of its Pharmaceuticals FY 2015 Action Plan. In this article, however, let’s look at some interesting wrinkles not necessarily contained in the document.

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This “Plain Jane” action plan, taken straight from the document, reads as follows:

“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM), is intended to facilitate operational and program alignment as FDA transitions to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, and well-designed and coordinated implementation.”

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