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FEDERAL · 21 CFR

Part 314 — Applications for FDA Approval to Market a New Drug

69 sections · Title 21: Food and Drugs

§ 314.1Scope of this part.
§ 314.2Purpose.
§ 314.3Definitions.
§ 314.50Content and format of an NDA.
§ 314.52Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.53Submission of patent information.
§ 314.54Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
§ 314.55Pediatric use information.
§ 314.56Nonprescription drug product with an additional condition for nonprescription use (ACNU).
§ 314.60Amendments to an unapproved NDA, supplement, or resubmission.
§ 314.65Withdrawal by the applicant of an unapproved application.
§ 314.70Supplements and other changes to an approved NDA.
§ 314.71Procedures for submission of a supplement to an approved application.
§ 314.72Change in ownership of an application.
§ 314.80Postmarketing reporting of adverse drug experiences.
§ 314.81Other postmarketing reports.
§ 314.90Waivers.
§ 314.92Drug products for which abbreviated applications may be submitted.
§ 314.93Petition to request a change from a listed drug.
§ 314.94Content and format of an ANDA.
§ 314.95Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.96Amendments to an unapproved ANDA.
§ 314.97Supplements and other changes to an approved ANDA.
§ 314.98Postmarketing reports.
§ 314.99Other responsibilities of an applicant of an ANDA.
§ 314.100Timeframes for reviewing applications and abbreviated applications.
§ 314.101Filing an NDA and receiving an ANDA.
§ 314.102Communications between FDA and applicants.
§ 314.103Dispute resolution.
§ 314.104Drugs with potential for abuse.
§ 314.105Approval of an NDA and an ANDA.
§ 314.106Foreign data.
§ 314.107Date of approval of a 505(b)(2) application or ANDA.
§ 314.108New drug product exclusivity.
§ 314.110Complete response letter to the applicant.
§ 314.120§ 314.120 [Reserved]
§ 314.122Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
§ 314.125Refusal to approve an NDA.
§ 314.126Adequate and well-controlled studies.
§ 314.127Refusal to approve an ANDA.
§ 314.150Withdrawal of approval of an application or abbreviated application.
§ 314.151Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
§ 314.152Notice of withdrawal of approval of an application or abbreviated application for a new drug.
§ 314.153Suspension of approval of an abbreviated new drug application.
§ 314.160Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
§ 314.161Determination of reasons for voluntary withdrawal of a listed drug.
§ 314.162Removal of a drug product from the list.
§ 314.170Adulteration and misbranding of an approved drug.
§ 314.200Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
§ 314.201Procedure for hearings.
§ 314.235Judicial review.
§ 314.410Imports and exports of new drugs.
§ 314.420Drug master files.
§ 314.430Availability for public disclosure of data and information in an application or abbreviated application.
§ 314.440Addresses for applications and abbreviated applications.
§ 314.445Guidance documents.
§ 314.500Scope.
§ 314.510Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 314.520Approval with restrictions to assure safe use.
§ 314.530Withdrawal procedures.
§ 314.540Postmarketing safety reporting.
§ 314.550Promotional materials.
§ 314.560Termination of requirements.
§ 314.600Scope.
§ 314.610Approval based on evidence of effectiveness from studies in animals.
§ 314.620Withdrawal procedures.
§ 314.630Postmarketing safety reporting.
§ 314.640Promotional materials.
§ 314.650Termination of requirements.