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Health & SafetyPro
FDA Adverse Event Reports
Request adverse event reports for specific drugs, devices, or food products submitted to the FDA.
Request Subject
Adverse Event Reports
Request Description
All adverse event reports, MedWatch submissions, and safety signals related to [PRODUCT/DRUG NAME] for the period of [DATE RANGE]. Please include individual case safety reports (ICSRs), periodic safety update reports, and any internal FDA communications regarding safety concerns.
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FDA
About this template: This template was drafted by practicing FOIA attorneys to help you request commonly sought government records. Customize the bracketed sections with your specific details before filing. Templates are starting points — you may need to adjust the language based on your particular situation.