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FEDERAL REGISTER · NOTICEMay 22, 2024NOTICE — NO LEGAL EFFECT

Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; 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
May 22, 2024
Document number
2024-11228
Docket
FDA-2024-N-0001
ABSTRACT

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products." The purpose of the public workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data.

Abstract as published in the Federal Register.

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The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

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