Public Citizen Challenges Timing Of AstraZeneca Crestor Adverse Event Reports
This article was originally published in The Pink Sheet Daily
Executive Summary
AstraZeneca "illegally" delayed the submission of 23 cases of serious adverse drug reactions by including them in quarterly reports rather than submitting them on an expedited basis, Public Citizen says. AstraZeneca maintains that rhabdomyolysis and renal failure are labeled events that do not require 15-day alert reports.