Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: FDA releases final guidance updating postapproval safety data standards, (Mar 5, 2026)

By WK Editorial Staff

The FDA announced the availability of a final guidance updating definitions, terminology, and standards for managing and reporting postapproval safety data, including newer data sources such as social media and patient support programs.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” issued on March 14, 2024, and the final guidance issued September 15, 2003 (Notice, 91 Fed. Reg. 10619 (Mar. 4, 2026)).

Dates. The announcement of the guidance is published in the Federal Register on March 4, 2026.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews