Medical Professional Publications

New FDA Policy for Drug & Device Development Services at Nationwide Children's Hospital

(From the December 2016 issue of Research Now)

A new Nationwide Children's Hospital policy has been issued to direct researchers and clinicians towards Drug and Device Development Services (DDDS) resources available when interacting with the Food and Drug Administration (FDA). The objective of this new policy is to ensure all faculty have access to and appropriately use the resources provided by DDDS at Nationwide Children's, led by Chris Shilling, MS, director.

The policy outlines the following for researchers and clinicians:

  1. Contact the DDDS office prior to any planned communication with the FDA; 
  2. And work with the Regulatory Affairs specialist assigned to support you with all communications or submissions to the FDA, including all Investigative New Drug and Investigative Device Exemption applications.

For more information, please contact the Drug and Device Development office at Regulatory@NationwideChildrens.org or 614-355-1827, or visit the DDDS website.

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Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000