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FEDERAL REGISTER · NOTICEJanuary 17, 2025NOTICE — NO LEGAL EFFECT

Optimizing Pregnancy Registries; Public Workshop

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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 CLOSE—
APPLIES TO · SPEQ TAGDrugBiologics
Document type
Notice
Agency
Health and Human Services Department
Published
January 17, 2025
Document number
2025-01164
Docket
FDA-2024-N-0001
ABSTRACT

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation program.

Abstract as published in the Federal Register.

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