Healthy INSIDER Podcast 77: Potential Implications of FDA's AER Database

Rachel Adams, managing editor, and Rick Kingston, Pharm.D., president, regulatory and scientific affairs at SafetyCall International, clinical professor of pharmacy at University of Minnesota, discuss the logistics of FDA's recently launched database for adverse event reports (AERs), along with potential implications.

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.

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