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General Provisions
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Biologics
Licensing
General Provisions
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Section
601.2
Applications for biologics licenses; procedures for filing.
Section
601.3
Complete response letter to the applicant.
Section
601.4
Issuance and denial of license.
Section
601.5
Revocation of license.
Section
601.6
Suspension of license.
Section
601.7
Procedure for hearings.
Section
601.8
Publication of revocation.
Section
601.9
Licenses; reissuance.