This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
AER Reporting in OxyElite Pro Hepatitis Outbreak: What Dietary Supplement Industry Can Learn
The 2013 hepatitis outbreak linked to USPlabs' OxyElite Pro dietary supplements highlighted the importance of FDA's adverse event reporting system. But it also demonstrated that the system is an imperfect one that is highly reliant on the vigilance of medical professionals and other third parties including industry. Takeaways include: *The hepatitis outbreak shows the limitations of FDA's MedWatch adverse event reporting program. *Medical and health officials in Hawaii were instrumental in identifying a potential health crisis. *Questions remain concerning USPlabs' role in monitoring and reporting adverse events to FDA.
May 25, 2016
Table of Contents
Register to view the full article
Registering as a member of Natural Products INSIDER will give you free access to premium content including digital magazines, webinars, whitepapers and more.