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If You Are A Manufacturer, Distributor Or User Facility, Go To The Fda's Medwatch 3500A Form Instruction Page To.

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The Fda Safety Information And Adverse Event Reporting Program;

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Web for purposes of this guidance document, in several locations, we refer to form fda 3500a as the “paper version” and the fda safety reporting portal as the “electronic version” of. 9/30/2018 see pra statement on reverse. Web medwatch is the fda reporting system for adverse events (aes), and form 3500a is used for adverse event reporting. The fda issued a revised medwatch form 3500a used by importers, distributors, manufacturers.

Web Revised Medwatch Form 3500A For Reporting Adverse Events.

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