2003 CFR Title 21, Volume 5

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
	314.1	Scope of this part.
	314.2	Purpose.
	314.3	Definitions.
	314.50	Content and format of an application.
	314.52	Notice of certification of invalidity or noninfringement of a patent.
	314.53	Submission of patent information.
	314.54	Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug.
	314.55	Pediatric use information.
	314.60	Amendments to an unapproved application.
	314.65	Withdrawal by the applicant of an unapproved application.
	314.70	Supplements and other changes to an approved application.
	314.71	Procedures for submission of a supplement to an approved application.
	314.72	Change in ownership of an application.
	314.80	Postmarketing reporting of adverse drug experiences.
	314.81	Other postmarketing reports.
	314.90	Waivers.
	314.92	Drug products for which abbreviated applications may be submitted.
	314.93	Petition to request a change from a listed drug.
	314.94	Content and format of an abbreviated application.
	314.95	Notice of certification of invalidity or noninfringement of a patent.
	314.96	Amendments to an unapproved abbreviated application.
	314.97	Supplements and other changes to an approved abbreviated application.
	314.98	Postmarketing reports.
	314.99	Other responsibilities of an applicant of an abbreviated application.
	314.100	Timeframes for reviewing applications and abbreviated applications.
	314.101	Filing an application and receiving an abbreviated new drug application.
	314.102	Communications between FDA and applicants.
	314.103	Dispute resolution.
	314.104	Drugs with potential for abuse.
	314.105	Approval of an application and an abbreviated application.
	314.106	Foreign data.
	314.107	Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act.
	314.108	New drug product exclusivity.
	314.110	Approvable letter to the applicant.
	314.120	Not approvable letter to the applicant.
	314.122	Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
	314.125	Refusal to approve an application.
	314.126	Adequate and well-controlled studies.
	314.127	Refusal to approve an abbreviated new drug application.
	314.150	Withdrawal of approval of an application or abbreviated application.
	314.151	Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
	314.152	Notice of withdrawal of approval of an application or abbreviated application for a new drug.
	314.153	Suspension of approval of an abbreviated new drug application.
	314.160	Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
	314.161	Determination of reasons for voluntary withdrawal of a listed drug.
	314.162	Removal of a drug product from the list.
	314.170	Adulteration and misbranding of an approved drug.
	314.200	Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
	314.201	Procedure for hearings.
	314.235	Judicial review.
	314.410	Imports and exports of new drugs.
	314.420	Drug master files.
	314.430	Availability for public disclosure of data and information in an application or abbreviated application.
	314.440	Addresses for applications and abbreviated applications.
	314.445	Guidance documents.
	314.500	Scope.
	314.510	Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
	314.520	Approval with restrictions to assure safe use.
	314.530	Withdrawal procedures.
	314.540	Postmarketing safety reporting.
	314.550	Promotional materials.
	314.560	Termination of requirements.
	314.600	Scope.
	314.610	Approval based on evidence of effectiveness from studies in animals.
	314.620	Withdrawal procedures.
	314.630	Postmarketing safety reporting.
	314.640	Promotional materials.
	314.650	Termination of requirements.