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- 21 CFR 600.2 · Mailing addresses.
- 21 CFR 600.3 · Definitions.
- 21 CFR 600.10 · Personnel.
- 21 CFR 600.11 · Physical establishment, equipment, animals, and care.
- 21 CFR 600.12 · Records.
- 21 CFR 600.13 · Retention samples.
- 21 CFR 600.14 · Reporting of biological product deviations by licensed manufacturers.
- 21 CFR 600.15 · Temperatures during shipment.
- 21 CFR 600.20 · Inspectors.
- 21 CFR 600.21 · Time of inspection.
- 21 CFR 600.22 · [Reserved]
- 21 CFR 600.80 · Postmarketing reporting of adverse experiences.
- 21 CFR 600.81 · Distribution reports.
- 21 CFR 600.82 · Notification of a permanent discontinuance or an interruption in manufacturing.
- 21 CFR 600.90 · Waivers.
- 21 CFR 601.2 · Applications for biologics licenses; procedures for filing.
- 21 CFR 601.3 · Complete response letter to the applicant.
- 21 CFR 601.4 · Issuance and denial of license.
- 21 CFR 601.5 · Revocation of license.
- 21 CFR 601.6 · Suspension of license.
- 21 CFR 601.7 · Procedure for hearings.
- 21 CFR 601.8 · Publication of revocation.
- 21 CFR 601.9 · Licenses; reissuance.
- 21 CFR 601.12 · Changes to an approved application.
- 21 CFR 601.14 · Regulatory submissions in electronic format.
- 21 CFR 601.15 · Foreign establishments and products: samples for each importation.
- 21 CFR 601.20 · Biologics licenses; issuance and conditions.
- 21 CFR 601.21 · Products under development.
- 21 CFR 601.22 · Products in short supply; initial manufacturing at other than licensed location.
- 21 CFR 601.27 · Pediatric studies.
- 21 CFR 601.28 · Annual reports of postmarketing pediatric studies.
- 21 CFR 601.29 · Guidance documents.
- 21 CFR 601.30 · Scope.
- 21 CFR 601.31 · Definition.
- 21 CFR 601.32 · General factors relevant to safety and effectiveness.
- 21 CFR 601.33 · Indications.
- 21 CFR 601.34 · Evaluation of effectiveness.
- 21 CFR 601.35 · Evaluation of safety.
- 21 CFR 601.40 · Scope.
- 21 CFR 601.41 · Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
- 21 CFR 601.42 · Approval with restrictions to assure safe use.
- 21 CFR 601.43 · Withdrawal procedures.
- 21 CFR 601.44 · Postmarketing safety reporting.
- 21 CFR 601.45 · Promotional materials.
- 21 CFR 601.46 · Termination of requirements.
- 21 CFR 601.50 · Confidentiality of data and information in an investigational new drug notice for a biological product.
- 21 CFR 601.51 · Confidentiality of data and information in applications for biologics licenses.
- 21 CFR 601.70 · Annual progress reports of postmarketing studies.
- 21 CFR 601.90 · Scope.
- 21 CFR 601.91 · Approval based on evidence of effectiveness from studies in animals.
- 21 CFR 601.92 · Withdrawal procedures.
- 21 CFR 601.93 · Postmarketing safety reporting.
- 21 CFR 601.94 · Promotional materials.
- 21 CFR 601.95 · Termination of requirements.
- 21 CFR 606.3 · Definitions.
- 21 CFR 606.20 · Personnel.
- 21 CFR 606.40 · Facilities.
- 21 CFR 606.60 · Equipment.
- 21 CFR 606.65 · Supplies and reagents.
- 21 CFR 606.100 · Standard operating procedures.
- 21 CFR 606.110 · Plateletpheresis, leukapheresis, and plasmapheresis.
- 21 CFR 606.120 · Labeling, general requirements.
- 21 CFR 606.121 · Container label.
- 21 CFR 606.122 · Circular of information.
- 21 CFR 606.140 · Laboratory controls.
- 21 CFR 606.145 · Control of bacterial contamination of platelets.
- 21 CFR 606.151 · Compatibility testing.
- 21 CFR 606.160 · Records.
- 21 CFR 606.165 · Distribution and receipt; procedures and records.
- 21 CFR 606.170 · Adverse reaction file.
- 21 CFR 606.171 · Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services.
- 21 CFR 607.1 · Scope.
- 21 CFR 607.3 · Definitions.
- 21 CFR 607.7 · Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
- 21 CFR 607.20 · Who must register and submit a blood product list.
- 21 CFR 607.21 · Times for establishment registration and blood product listing.
- 21 CFR 607.22 · How to register establishments and list blood products.
- 21 CFR 607.25 · Information required for establishment registration and blood product listing.
- 21 CFR 607.26 · Amendments to establishment registration.
- 21 CFR 607.30 · Updating blood product listing information.
- 21 CFR 607.31 · Additional blood product listing information.
- 21 CFR 607.35 · Blood product establishment registration number.
- 21 CFR 607.37 · Public disclosure of establishment registration and blood product listing information.
- 21 CFR 607.39 · Misbranding by reference to establishment registration, validation of registration, or to registration number.
- 21 CFR 607.40 · Establishment registration and blood product listing requirements for foreign blood product establishments.
- 21 CFR 607.65 · Exemptions for blood product establishments.
- 21 CFR 607.80 · Applicability of part 607 to licensed devices.
- 21 CFR 610.1 · Tests prior to release required for each lot.
- 21 CFR 610.2 · Requests for samples and protocols; official release.
- 21 CFR 610.9 · Equivalent methods and processes.
- 21 CFR 610.10 · Potency.
- 21 CFR 610.11-610.11a · -610.11a [Reserved]
- 21 CFR 610.12 · Sterility.
- 21 CFR 610.13 · Purity.
- 21 CFR 610.14 · Identity.
- 21 CFR 610.15 · Constituent materials.
- 21 CFR 610.16 · Total solids in serums.
- 21 CFR 610.17 · Permissible combinations.
- 21 CFR 610.18 · Cultures.
- 21 CFR 610.39 · Definitions.