U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-0803
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” published in 2003. The draft guidance is intended is to clarify the use of new or increasingly used data sources ( e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting.

    Submit Comments

    Submit Comments Online

    You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

    If unable to submit comments online, please mail written comments to:

    Dockets Management
    Food and Drug Administration
    5630 Fishers Lane, Rm 1061
    Rockville, MD 20852

    All written comments should be identified with this document's docket number: FDA-2024-D-0803.

     
    Back to Top