FDA updates adverse event reporting policies

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The FDA has released new standard operating policies and procedures for staff of the Center for Biologics Evaluation and Research (CBER). Effective Nov. 1, the document will guide staff in developing and posting quarterly lists of potential serious risks, as identified by the Adverse Event Reporting System (AERS).

The information applies to all marketed drugs and therapeutic biologics regulated by CBER. The policy requires routine examinations of the AERS and direct reports submitted by consumers, healthcare providers and others to the FDA. Issues determined to be of potential serious risk are to be posted on the internet and new potential signals of serious risk will be posted quarterly.

Click here for the new policy.