21 CFR
Part 601 Licensing
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
Subpart C - Biologics Licensing
- § 601.12 Changes to an approved application 9 × 483
- § 601.14 Regulatory submissions in electronic format
- § 601.15 Foreign establishments and products: samples for each importation
- § 601.20 Biologics licenses; issuance and conditions
- § 601.21 Products under development
- § 601.22 Products in short supply; initial manufacturing at other than licensed location
- § 601.27 Pediatric studies
- § 601.28 Annual reports of postmarketing pediatric studies
- § 601.29 Guidance documents
Subpart D - Diagnostic Radiopharmaceuticals
- § 601.30 Scope
- § 601.31 Definition
- § 601.32 General factors relevant to safety and effectiveness
- § 601.33 Indications
- § 601.34 Evaluation of effectiveness
- § 601.35 Evaluation of safety
Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
- § 601.40 Scope
- § 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
- § 601.42 Approval with restrictions to assure safe use
- § 601.43 Withdrawal procedures
- § 601.44 Postmarketing safety reporting
- § 601.45 Promotional materials
- § 601.46 Termination of requirements
Subpart F - Confidentiality of Information
- § 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product
- § 601.51 Confidentiality of data and information in applications for biologics licenses