← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEDecember 31, 2024NOTICE — NO LEGAL EFFECT

Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period

What this record is not

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 3, 2025 · closed
APPLIES TO · SPEQ TAGNot tagged
Document type
Notice
Agency
Health and Human Services Department
Published
December 31, 2024
Comments close
March 3, 2025
Document number
2024-31365
Docket
FDA-2024-N-2980
ABSTRACT

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments notice entitled "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products," published in the Federal Register of July 25, 2024. FDA is reopening the comment period to update comments and to receive any new information.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

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.

View on federalregister.gov →

That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.

Create a free account