2002 CFR Title 21, Volume 7

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 601--LICENSING
	601.2	Applications for biologics licenses; procedures for filing.
	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.
	601.12	Changes to an approved application.
	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.
	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.
	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.
	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.
	601.70	Annual progress reports of postmarketing studies.