|
Section 601.2
|
Complete response letter to the applicant |
|
Section 601.3
|
Issuance and denial of license |
|
Section 601.4
|
Revocation of license |
|
Section 601.5
|
Suspension of license |
|
Section 601.6
|
Procedure for hearings |
|
Section 601.7
|
Publication of revocation |
|
Section 601.8
|
Licenses; reissuance |
|
Section 601.9
|
Changes to an approved application |
|
Section 601.12
|
Regulatory submissions in electronic format |
|
Section 601.14
|
Foreign establishments and products: samples for each importation |
|
Section 601.15
|
Biologics licenses; issuance and conditions |
|
Section 601.20
|
Products under development |
|
Section 601.21
|
Products in short supply; initial manufacturing at other than licensed location |
|
Section 601.22
|
Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, |
|
Section 601.25
|
Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under |
|
Section 601.26
|
Pediatric studies |
|
Section 601.27
|
Annual reports of postmarketing pediatric studies |
|
Section 601.28
|
Guidance documents |
|
Section 601.29
|
Scope |
|
Section 601.30
|
Definition |
|
Section 601.31
|
General factors relevant to safety and effectiveness |
|
Section 601.32
|
Indications |
|
Section 601.33
|
Evaluation of effectiveness |
|
Section 601.34
|
Evaluation of safety |
|
Section 601.35
|
Scope |
|
Section 601.40
|
Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity |
|
Section 601.41
|
Approval with restrictions to assure safe use |
|
Section 601.42
|
Withdrawal procedures |
|
Section 601.43
|
Postmarketing safety reporting |
|
Section 601.44
|
Promotional materials |
|
Section 601.45
|
Termination of requirements |
|
Section 601.46
|
Confidentiality of data and information in an investigational new drug notice for a biological product |
|
Section 601.50
|
Confidentiality of data and information in applications for biologics licenses |
|
Section 601.51
|
Annual progress reports of postmarketing studies |
|
Section 601.70
|
Scope |
|
Section 601.90
|
Approval based on evidence of effectiveness from studies in animals |
|
Section 601.91
|
Withdrawal procedures |
|
Section 601.92
|
Postmarketing safety reporting |
|
Section 601.93
|
Promotional materials |
|
Section 601.94
|
Termination of requirements |
|
Section 601.95
|
Definitions |