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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-1307
Requests that the FDA Reverse its decision to classify desiccated thyroid extract (DTE) as a biological product under the PHS Act; Clarify that the August 6, 2025 Notice to Industry; Affirm that natural thyroid products should, if approved, proceed through the drug approval pathway under section 505 of the FD&C Act; regarding the classification and regulation of DTE products
Documents
7
Comments
1
Key Dates
Comment Period OpensFeb 5, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Comment Statistics
Total Comments
1
Keywords
CDER
Citizen Petition
Alliance for Pharmacy Compounding
Reverse its
decision to classify desiccated thyroid extract
as a biological product under the PHS Act
Clarify
that the August 6 2025 Notice to Industry
Data from Regulations.gov