First Year Of Mandatory Reports Shows Safety-Monitoring Value Of AER Data
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
Hydroxycut Recall Sheds Light On Pros And Cons Of AER System
Identifying possible risks linked to dietary supplements - such as the recalled line of Hydroxycut weight-loss products - is challenging because FDA generally works with post-market information, an agency executive said
FDA Audits Of Supplement, OTC AERs Likely Starting This Year – Consultant
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
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC