Dear All:
I would appreciate any insight about recent experiences with the CDER Ombudsman. Any preference on initial contact - phone or email? How long did it take to get a response? Was the resolution of the matter satisfactory to the company? Any issues with dealing with the FDA Division staff after approaching the Ombudsman? Any comments would be helpful as we decide whether to approach the Agency through the Ombudsman.
Best regards,
Sue
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M. Sue Preston
VP, Regulatory & Quality
Oakland CA
United States
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