Post-Market Surveillance & Adverse Event Reports (April 2023)

 Post-Market Surveillance & Adverse Event Reports (April 2023)
Manufacturers of dietary supplements play a key role in consumer safety. If an adverse event associated with a dietary supplement occurs, the manufacturer is responsible for documenting and thoroughly investigating the issue. As for serious adverse events reports (SAERs), manufacturers are obligated to document and submit any such reports that meet the law’s definition of “serious” to the U.S. Food & Drug Administration (FDA) in a timely matter. Failure to submit SAERs to FDA has consequences.
Item Number: WEB021
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