FDA Audits Of Supplement, OTC AERs Likely Starting This Year – Consultant
This article was originally published in The Tan Sheet
Executive Summary
Dietary supplement and OTC drug companies should not become accustomed to the "honeymoon" FDA has allowed from adverse event reporting compliance audits, according to Rick Kingston, an executive with SafetyCall adverse event reporting call center
You may also be interested in...
Burton Bill Would Move Up New Dietary Ingredient Grandfather Date To 2007
Rep. Burton offers legislation to move up from 1994 to 2007 the date delineating old from new dietary ingredients. Despite the appeal, supplement trade groups are leery of opening up DSHEA to amendment.
Burton Bill Would Move Up New Dietary Ingredient Grandfather Date To 2007
Rep. Burton offers legislation to move up from 1994 to 2007 the date delineating old from new dietary ingredients. Despite the appeal, supplement trade groups are leery of opening up DSHEA to amendment.
First Year Of Mandatory Reports Shows Safety-Monitoring Value Of AER Data
The spike in dietary supplement adverse event reports in 2008 demonstrates that mandatory reporting gives FDA a more effective safety surveillance tool than voluntary reporting alone