Roche ADE reporting delays cited in FDA warning letter; firm says 15-day compliance rate now at 96%.
Executive Summary
ROCHE MEDWATCH FORM "MISCODINGS" CITED IN FDA WARNING LETTER sent to the company Jan. 5. The letter charges that Roche incorrectly dated several MedWatch adverse event reporting forms, and, as a result, missed the 15-day reporting deadline. For example, FDA said, a report for oral Ticlid submitted March 29, 1996 was misdated April 16 and a report involving oral Invirase submitted Aug. 15, 1996 was misdated Aug. 30.