CFR /  Title 21  /  Part 314: Applications For Fda Approval To Market A New Drug

Section No.	Description
Section 314.1	Purpose
Section 314.2	Definitions
Section 314.3	Content and format of an application
Section 314.50	Notice of certification of invalidity or noninfringement of a patent
Section 314.52	Submission of patent information
Section 314.53	Procedure for submission of an application requiring investigations for approval of a new indication for, or other change
Section 314.54	Pediatric use information
Section 314.55	Amendments to an unapproved application, supplement, or resubmission
Section 314.60	Withdrawal by the applicant of an unapproved application
Section 314.65	Supplements and other changes to an approved application
Section 314.70	Procedures for submission of a supplement to an approved application
Section 314.71	Change in ownership of an application
Section 314.72	Postmarketing reporting of adverse drug experiences
Section 314.80	Postmarketing reporting of adverse drug experiences
Section 314.80	Other postmarketing reports
Section 314.81	Waivers
Section 314.90	Obtaining a reduction in the discontinuance notification period
Section 314.91	Drug products for which abbreviated applications may be submitted
Section 314.92	Petition to request a change from a listed drug
Section 314.93	Content and format of an abbreviated application
Section 314.94	Notice of certification of invalidity or noninfringement of a patent
Section 314.95	Amendments to an unapproved abbreviated application
Section 314.96	Supplements and other changes to an approved abbreviated application
Section 314.97	Postmarketing reports
Section 314.98	Postmarketing reports
Section 314.98	Other responsibilities of an applicant of an abbreviated application
Section 314.99	Timeframes for reviewing applications and abbreviated applications
Section 314.100	Filing an application and receiving an abbreviated new drug application
Section 314.101	Communications between FDA and applicants
Section 314.102	Dispute resolution
Section 314.103	Drugs with potential for abuse
Section 314.104	Approval of an application and an abbreviated application
Section 314.105	Foreign data
Section 314.106	Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act
Section 314.107	New drug product exclusivity
Section 314.108	Complete response letter to the applicant
Section 314.110	Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no
Section 314.122	Refusal to approve an application
Section 314.125	Adequate and well-controlled studies
Section 314.126	Refusal to approve an abbreviated new drug application
Section 314.127	Withdrawal of approval of an application or abbreviated application
Section 314.150	Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act
Section 314.151	Notice of withdrawal of approval of an application or abbreviated application for a new drug
Section 314.152	Suspension of approval of an abbreviated new drug application
Section 314.153	Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn
Section 314.160	Determination of reasons for voluntary withdrawal of a listed drug
Section 314.161	Removal of a drug product from the list
Section 314.162	Adulteration and misbranding of an approved drug
Section 314.170	Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing
Section 314.200	Procedure for hearings
Section 314.201	Judicial review
Section 314.235	Imports and exports of new drugs
Section 314.410	Drug master files
Section 314.420	Availability for public disclosure of data and information in an application or abbreviated application
Section 314.430	Addresses for applications and abbreviated applications
Section 314.440	Guidance documents
Section 314.445	Scope
Section 314.500	Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity
Section 314.510	Approval with restrictions to assure safe use
Section 314.520	Withdrawal procedures
Section 314.530	Postmarketing safety reporting
Section 314.540	Promotional materials
Section 314.550	Termination of requirements
Section 314.560	Scope
Section 314.600	Approval based on evidence of effectiveness from studies in animals
Section 314.610	Withdrawal procedures
Section 314.620	Postmarketing safety reporting
Section 314.630	Promotional materials
Section 314.640	Termination of requirements
Section 314.650	Scope