1999 CFR Title 26, Volume 17

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 601--LICENSING
	601.1	Two forms of licenses.
	601.2	Applications for establishment and product licenses; procedures for filing.
	601.2	Applications for establishment and product licenses; procedures for filing.
	601.3	License forms.
	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.
	601.10	Establishment licenses; issuance and conditions.
	601.12	Changes to an approved application.
	601.12	Changes to an approved application.
	601.20	Product licenses; issuance and conditions.
	601.21	Products under development.
	601.22	Products in short supply; initial manufacturing at other than licensed establishment.
	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.
	601.33	Samples for each importation.
	601.37	Annual reports of postmarketing pediatric studies.
	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 establishment and product licenses.