Title 21, Part 601 — Licensing
39 sections
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.
Section 601.12
Changes to an approved application.
Section 601.14
Regulatory submissions in electronic format.
Section 601.15
Foreign establishments and products: samples for each importation.
Section 601.20
Biologics licenses; issuance and conditions.
Section 601.21
Products under development.
Section 601.22
Products in short supply; initial manufacturing at other than licensed location.
Section 601.27
Pediatric studies.
Section 601.28
Annual reports of postmarketing pediatric studies.
Section 601.29
Guidance documents.
Section 601.30
Scope.
Section 601.31
Definition.
Section 601.32
General factors relevant to safety and effectiveness.
Section 601.33
Indications.
Section 601.34
Evaluation of effectiveness.
Section 601.35
Evaluation of safety.
Section 601.40
Scope.
Section 601.41
Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
Section 601.42
Approval with restrictions to assure safe use.
Section 601.43
Withdrawal procedures.
Section 601.44
Postmarketing safety reporting.
Section 601.45
Promotional materials.
Section 601.46
Termination of requirements.
Section 601.50
Confidentiality of data and information in an investigational new drug notice for a biological product.
Section 601.51
Confidentiality of data and information in applications for biologics licenses.
Section 601.70
Annual progress reports of postmarketing studies.
Section 601.90
Scope.
Section 601.91
Approval based on evidence of effectiveness from studies in animals.
Section 601.92
Withdrawal procedures.
Section 601.93
Postmarketing safety reporting.
Section 601.94
Promotional materials.
Section 601.95
Termination of requirements.