Sofamor Danek asking FDA to clarify "Dear Doctor" letter promotions policy.
This article was originally published in The Gray Sheet
Executive SummarySOFAMOR DANEK TO SEEK CLARIFICATION OF FDA POLICY ON "DEAR DOCTOR" LETTERS in upcoming correspondence to the agency. Responding to an Aug. 22 letter from FDA regarding promotion of the TSRH Pedicle Spinal Implant System, the company wants the agency to clarify what information on device warnings must be included in Dear Doctor letters.
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