To Speed Guidance Development, CDRH Will Need More Resources – Shuren
By
Jessica Bylander / Email the Author / “The Gray Sheet” May 30, 2011, Vol. 37, No. 22
Regulatory / Word Count: 1292 / Article # 01110530011
Executive Summary
FDA's device center wants to improve the predictability of its product review process with more guidance documents, but lacks the personnel and resources to fully deliver, according to center director Jeffrey Shuren.
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