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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 314APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
 

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 application.
   § 314.52 - Notice of certification of invalidity or noninfringement of a patent.
   § 314.53 - Submission of patent information.
   § 314.54 - Procedure for submission of an 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 application, supplement, or resubmission.
   § 314.65 - Withdrawal by the applicant of an unapproved application.
   § 314.70 - Supplements and other changes to an approved application.
   § 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.
   § 314.91 - Obtaining a reduction in the discontinuance notification period.

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 abbreviated application.
   § 314.95 - Notice of certification of invalidity or noninfringement of a patent.
   § 314.96 - Amendments to an unapproved abbreviated application.
   § 314.97 - Supplements and other changes to an approved abbreviated application.
   § 314.98 - Postmarketing reports.
   § 314.99 - Other responsibilities of an applicant of an abbreviated application.

Subpart D--FDA Action on Applications and Abbreviated Applications
   § 314.100 - Timeframes for reviewing applications and abbreviated applications.
   § 314.101 - Filing an application and receiving an abbreviated new drug application.
   § 314.102 - Communications between FDA and applicants.
   § 314.103 - Dispute resolution.
   § 314.104 - Drugs with potential for abuse.
   § 314.105 - Approval of an application and an abbreviated application.
   § 314.106 - Foreign data.
   § 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act.
   § 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 application.
   § 314.126 - Adequate and well-controlled studies.
   § 314.127 - Refusal to approve an abbreviated new drug application.
   § 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 -
   § 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

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