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GUIDANCE DOCUMENT

M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines July 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-2754
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines.”  The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines general principles on planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products). The draft guidance includes recommendations and high-level best practices for the conduct of these studies. The draft guidance is intended to streamline the development and regulatory assessment of postmarketing pharmacoepidemiological safety studies that include Real-World Data. This guidance also seeks to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision making in response to study results.

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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-2754.

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