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FEDERAL REGISTER · NOTICEMarch 13, 2025NOTICE — NO LEGAL EFFECT

E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEMar 31, 2025 · closed
APPLIES TO · SPEQ TAGNot tagged
Document type
Notice
Agency
Health and Human Services Department
Published
March 13, 2025
Comments close
March 31, 2025
Document number
2025-04026
Docket
FDA-2024-D-5601
ABSTRACT

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance for industry entitled "E6(R3) Good Clinical Practice: Annex 2," announced in the Federal Register of December 30, 2024. The Agency is taking this action to allow interested persons additional time to submit comments.

Abstract as published in the Federal Register.

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