FDA Accepting Public Comments for Adverse Event Reporting Submission Forms

March 16, 2018

The FDA requested comments on planned modifications to its MedWatch system that will impact existing forms used to report adverse events, including FDA 3500, 3500A and 3500B.

“The proposed changes are regulatory driven, improving the Centers’ work, and improving report processing,” the agency said in its Federal Register notice.

In addition, the agency is seeking input on the translation of consumer form 3500B into Spanish and other languages.

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