The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.

CDER director Janet Woodcock recently said these are her agencies “front burner” priorities:
• Implementing and clarifying statutory provisions on drug compounding
• Meeting Generic Drug User Fee Amendments review goals that went into effect Oct. 1, 2014
• Continue the build out of the Office of Generic Drugs “super office”
• Build out the Office of Pharmaceutical Quality
• Implement and continue to develop Program Alignment Group agreements with the Office of Regulatory Affairs

She singled out the implementation of a new process, data, and document management IT system as a “big deal” goal this year.

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