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Home » Woodcock Raps Outsourcer for Failing to Report AERs
Woodcock Raps Outsourcer for Failing to Report AERs
An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency.