Supplement AER Under-Reporting Marks Tip Of Compliance Iceberg – FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.
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Supplement AER Compliance Costs Exceed FDA Estimates – Industry
FDA’s estimate of supplement AER costs does not consider that firms must thoroughly investigate and evaluate all reports to determine whether they are serious and maintain records of reports, industry trade groups say.
Supplement AER Compliance Costs Exceed FDA Estimates – Industry
FDA’s estimate of supplement AER costs does not consider that firms must thoroughly investigate and evaluate all reports to determine whether they are serious and maintain records of reports, industry trade groups say.