FDA’s Promotional Enforcement Still Playing It Safe
Even with letter citing Spanish video for Oxtellar seizure, US regulatory agency likely to issue record low number of letters this year.
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Murky enforcement environment has probably contributed to FDA's record-low number of letters, but detailing material for ConZip failed to include risk information and important limitations of use for the tramadol extended-release product.
Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.