Nov 3 -- The Food and Drug Administration (FDA, the Agency, or we) is requesting comments on the topics discussed at a public workshop entitled “Advancing Premarket Safety Analytics Workshop” held on September 14, 2022. The purpose of the public workshop was to present FDA's work and perspective on premarket review of safety data. Either electronic or written comments on this public workshop must be submitted by December 5, 2022.
Because of a lack of standardization of safety data analysis and visualization, inconsistencies have been noted in how adverse events are defined, categorized, analyzed, and presented in marketing applications. The FDA Center for Drug Evaluation and Research's (CDER's) Office of New Drugs (OND) led the development of two documents to facilitate internal review of safety data. The first document, “FDA Medical Queries,” provides a standardized approach to group preferred terms of adverse events using “Medical Dictionary for Regulatory Activities” (MedDRA) terminology. The second document, “Standard Safety Tables and Figures Integrated Guide,” provides standardized methods for visualization of clinical trial safety data into tables and figures. FDA values transparency and collaboration with external stakeholders; therefore, both documents are available for public comment through the docket.
At the public workshop entitled “Advancing Premarket Safety Analytics Workshop,” CDER's OND presented its work and perspective related to safety analytics. The workshop provided presentations from FDA staff on the two documents “FDA Medical Queries” and “Standard Safety Tables and Figures Integrated Guide ” (meeting materials available at
https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics). The workshop also included panel discussions with industry representatives on “Stakeholder Perspectives Exploring Premarket Adverse Event Grouping” and “Examining Strategies for Adverse Event Analysis.” FDA documents were intended as a starting point for broader discussions on best practices and innovative approaches for advancing premarket safety signal analytics. We are also seeking comment on the topics discussed at the workshop.
Public Workshop: Advancing Premarket Safety Analytics Workshop -- documents and comments
https://www.regulations.gov/docket/FDA-2022-N-1961
FRN:
https://www.federalregister.gov/d/2022-23925
