Surveillance of Adverse Events for Dietary Supplements

It’s been 10 years since mandatory adverse event reporting (AER) for dietary supplements and OTC drugs has been in place.  During that time there has been an evolution of systems and processes associated with AERs.  The focus has shifted from manufacturers simply meeting the letter of the law and filing Serious AEs with the FDA to them being held accountable for understanding their entire AE experience and being able to demonstrate the safety of their products with effective signal detection for safety issues which is the cornerstone of effective post market surveillance (PMS).  Learn about PMS best practices and how it ensures product sustainability, patient safety and consumer confidence.  Read more…