Podcast: Potential Implications of FDA’s AER Database

As previously published and shared on Natural Products Insider.

In an effort to promote transparency, FDA improved access to adverse events reports (AERs) via an online database that provides a variety of information in a search-friendly format. Though the database is intended to be a tool, the type and breadth of information, along with how the information is presented, could lead to more questions than answers. At the International Conference on the Science of Botanicals in Oxford, Mississippi, April 3-6, Rick Kingston, Pharm.D., president, regulatory and scientific affairs and senior clinical toxicologist at SafetyCall International, discussed the logistics of the new database, along with potential implications.

In this episode, Rachel Adams, managing editor, and Kingston discuss:

  • The breadth of information provided by the new database;
  • Whether the information can be used to develop safety signals; and
  • Potential unintended consequences of the database based on the breadth of information and how the information is presented.

Links and Resources:

CFSAN Adverse Event Reporting System