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FDA Estimates Dollar Costs For Adverse Event Labeling But Doubts Persist

This article was originally published in The Tan Sheet

Executive Summary

FDA's estimate of nearly $44 million for the dietary supplement industry to revise labels to comply with the adverse event reporting law may understate the actual burden by leaving out some key costs

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Final AER Guidance Requires Full Address, Recommends Prefatory Language

In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs

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