Federal Register Notice: FDA is seeking public comment on the FDA guidance for industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application. The guidance document provides recommendations on postmarketing serious adverse event reporting for over-the-counter human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Comments should be submitted by 3/24. To view this notice, click here.