Figure 1: Illustration of the resources (from FDA’s MedWatch and Drugs@FDA) and the process used to extract, filter, and verify, candidate test cases for the reference standard.
From: A time-indexed reference standard of adverse drug reactions
(1) Initial candidate test cases are obtained from FDA’s MedWatch monthly summaries, which provides a table of drugs (e.g., Ampyra) whose labels have been revised to include new safety information. (2) The events associated with each drug whose label was revised (e.g., Anaphylaxis) are obtained from the ‘detailed view’ linked to each row of a monthly summary Table. (3) The labels and revision history of each drug is obtained from Drugs@FDA to verify the labeling revision, and ensure that the candidate test case is indeed new and not qualified by special conditions.
