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.
- § 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
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.