21 CFR Part 314
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- 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.
- § 314.56 Nonprescription drug product with an additional condition for nonprescription use (ACNU).
- § 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.
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