Why is FDA posting a list outside the usual quarterly timeframe?
The potential signals that FDA posts to this web page are derived in part from a computer tracking system in CDER. In April 2020, CDER made effective a new Manual of Policies and Procedures (MAPP) 4121.3 titled “Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS)”. Implementation of the NISS MAPP completed the transition of the computer tracking system from Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) to the Lifecycle Signal Tracker (LiST).
During the transition period from April 2018 to March 2020, when the NISS process was piloted and LiST was developed, an administrative error resulted in the omission of certain Tracked Safety Issues (TSIs) from the quarterly reports. CDER is publishing a separate report listing the signals that were not included in the previously posted quarterly reports. Although these safety signals were not posted in the quarterly reports when the signals were identified and initially under evaluation by FDA, the findings of FDA were summarized and publicly communicated as appropriate (e.g., in Drug Safety Communications or updates to product labeling).
Has FDA previously posted a list outside the usual quarterly timeframe?
FDA has previously posted a list outside of the quarterly timeframe when the agency entered Tracked Safety Issues (TSIs) into DARRTS that were not previously entered for the interval from January, 2012 to April, 2015, adding to the TSIs already in DARRTS for that time frame. Although these TSIs were not entered into the tracking system when the signals were identified and initially under evaluation by FDA, the findings of FDA were summarized and publicly communicated as appropriate (e.g. in Drug Safety Communications or updates to product labeling).