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ARTICLE · 22 NOVEMBER 2012

New Adverse Event Report Requirements For Dietary Supplements

Rumberger, Kirk & Caldwell, P.A.
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The FDA published updated guidelines for dietary supplement manufacturers, distributors and sellers outlining their obligations to report serious adverse reactions (SAEs) regarding their products to the federal government.

United StatesConsumer Protection
Daniel Gerber
Daniel Gerber
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The FDA published updated guidelines for dietary supplement manufacturers, distributors and sellers outlining their obligations to report serious adverse reactions (SAEs) regarding their products to the federal government.  Rumberger Kirk & Caldwell attorney Dan Gerber discusses the reporting requirements and what manufacturers can do to ensure that they are compliant.

Related Questions

The FDA defines an SAE as "a complication that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above."

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