TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
Subpart A - General Provisions
§ 314.1 - Scope of this part.
§ 314.2 - Purpose.
§ 314.3 - Definitions.
Subpart B - Applications
§ 314.50 - Content and format of an NDA.
§ 314.52 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.53 - Submission of patent information.
§ 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.
§ 314.55 - Pediatric use information.
§ 314.60 - Amendments to an unapproved NDA, supplement, or resubmission.
§ 314.65 - Withdrawal by the applicant of an unapproved application.
§ 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.
Subpart C - Abbreviated Applications
§ 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.
Subpart D - FDA Action on Applications and Abbreviated Applications
§ 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 - [Reserved]
§ 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.
Subpart E - Hearing Procedures for New Drugs
§ 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.
Subpart F [Reserved]
Subpart G - Miscellaneous Provisions
§ 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.
Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§ 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.
Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
§ 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.
| 
