date:Nov 19, 2012
symptoms like vomiting, crying, anxiety with an outcome of visited a health care provider, visited an ER.
Regulatory attorneys agree that maintaining public safety is important, but undue scrutiny of products as a result of the mandatory reporting system can hurt industry, said Mark Gardner, a lawyer with Minnesota law firm DuVal Associates who specializes in FDA work.
Its terrible when someone is injured, Gardner said. But the broader policy question is should we over-react to a rare event