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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 601Subpart A - Subpart A—General Provisions
§ 601.2 - Applications for biologics licenses; procedures for filing.
§ 601.3 - Complete response letter to the applicant.
§ 601.4 - Issuance and denial of license.
§ 601.5 - Revocation of license.
§ 601.6 - Suspension of license.
§ 601.7 - Procedure for hearings.
§ 601.8 - Publication of revocation.
§ 601.9 - Licenses; reissuance.
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