Reprinted with permission from the Food and Drug Law Institute's Update magazine, March/April 2018.

In an agency where it takes as many as 550 days to hire, change is coming rapidly, not only in streamlining hiring practices, but in rapid approval programs for medical devices and generic drugs. Regulation by the U.S. Food and Drug Administration (FDA or the agency) has taken a collaborative and educational approach where streamlining and efficiency are the modern mantras of the new mandates. Policy changes and new guidance documents are being issued quickly, as the ideas that have dwelled restlessly in the thoughts of Center Directors are being launched into tangible actions. Transparency has become the new norm. Read More

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