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Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

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DRUGS FOR HUMAN USE - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

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Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Description

Official eCFR Link

§314.1 - Scope of this part.

§314.100 - Timeframes for reviewing applications and abbreviated applications.

§314.101 - Filing an NDA and receiving an ANDA.

§314.102 - Communications between FDA and applicants.

§314.103 - Dispute resolution.

§314.104 - Drugs with potential for abuse.

§314.105 - Approval of an NDA and an ANDA.

§314.106 - Foreign data.

§314.107 - Date of approval of a 505(b)(2) application or ANDA.

§314.108 - New drug product exclusivity.

§314.110 - Complete response letter to the applicant.

§314.120 - Unknown

§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 NDA.

§314.126 - Adequate and well-controlled studies.

§314.127 - Refusal to approve an ANDA.

§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- Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.

§314.2 - Purpose.

§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.

§314.3 - Definitions.

§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.

§314.50 - Content and format of an NDA.

§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.

§314.52 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

§314.520 - Approval with restrictions to assure safe use.

§314.53 - Submission of patent information.

§314.530 - Withdrawal procedures.

§314.54 - Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.

§314.540 - Postmarketing safety reporting.

§314.55 - Pediatric use information.

§314.550 - Promotional materials.

§314.560 - Termination of requirements.

§314.60 - Amendments to an unapproved NDA, supplement, or resubmission.

§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.

§314.65 - Withdrawal by the applicant of an unapproved application.

§314.650 - Termination of requirements.

§314.70 - Supplements and other changes to an approved NDA.

§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 ANDA.

§314.95 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

§314.96 - Amendments to an unapproved ANDA.

§314.97 - Supplements and other changes to an approved ANDA.

§314.98 - Postmarketing reports.

§314.99 - Other responsibilities of an applicant of an ANDA.