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AER Claims More Transparent?

Dietary Supplements,FDA,Regulatory,Sports Nutrition

A FDA Transparency Task Force proposed 21 suggestions to help consumers, industry and others learn how FDA operates and behaves in the manner it does.  One of those suggestions was to provide the public with online information about adverse event reports.  Though they recommend that such online information should come with a clear disclaimer about the limits of the information, such a database, even if it was updated regularly, could create huge headaches for industry.  In slow economic times everyone is looking for ways to work and make money – including plaintiff class action and personal injury lawyers.  To allow them to sift through the database may create substantial risk of frivolous but extortive lawsuits.  However, this does not mean one should not comply with the rules regarding AERs and, most importantly, have written SOPs on how to maintain a thorough and accurate database of AERs.

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