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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 601 - Licensing |
| Subpart A - General Provisions |
| § 601.1 - Two forms of licenses. |
| § 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 B - XXX |
| § 601.10 - Establishment licenses; issuance and conditions. |
| Subpart C - Biologics Licensing |
| § 601.12 - Changes to an approved application. |
| § 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. |
| § 601.25 - Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. |
| § 601.26 - Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. |
| § 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. |
| Subpart G - Postmarketing Studies |
| § 601.70 - Annual progress reports of postmarketing studies. |
| Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible |
| § 601.90 - Scope. |
| § 601.91 - Approval based on evidence of effectiveness from studies in animals. |
| § 601.92 - Withdrawal procedures. |
| § 601.93 - Postmarketing safety reporting. |
| § 601.94 - Promotional materials. |
| § 601.95 - Termination of requirements. |