21 C.F.R. PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart A--GENERAL PROVISIONS
Subpart B--APPLICATIONS
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| Content and format of an application.
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| Notice of certification of invalidity or noninfringement of a patent.
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| Submission of patent information.
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| Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug.
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| Pediatric use information.
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| Amendments to an unapproved application.
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| Withdrawal by the applicant of an unapproved application.
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| Supplements and other changes to an approved application.
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| Procedures for submission of a supplement to an approved application.
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| Change in ownership of an application.
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| Postmarketing reporting of adverse drug experiences.
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| Other postmarketing reports.
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Subpart C--ABBREVIATED APPLICATIONS
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| Drug products for which abbreviated applications may be submitted.
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| Petition to request a change from a listed drug.
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| Content and format of an abbreviated application.
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| Notice of certification of invalidity or noninfringement of a patent.
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| Amendments to an unapproved abbreviated application.
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| Supplements and other changes to an approved abbreviated application.
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| Other responsibilities of an applicant of an abbreviated application.
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Subpart D--FDA ACTION ON APPLICATIONS AND ABBREVIATED APPLICATIONS
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| Timeframes for reviewing applications and abbreviated applications.
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| Filing an application and receiving an abbreviated new drug application.
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| Communications between FDA and applicants.
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| Drugs with potential for abuse.
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| Approval of an application and an abbreviated application.
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| Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act.
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| New drug product exclusivity.
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| Approvable letter to the applicant.
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| Not approvable letter to the applicant.
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| Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
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| Refusal to approve an application.
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| Adequate and well-controlled studies.
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| Refusal to approve an abbreviated new drug application.
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| Withdrawal of approval of an application or abbreviated application.
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| Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
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| Notice of withdrawal of approval of an application or abbreviated application for a new drug.
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| Suspension of approval of an abbreviated new drug application.
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| Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
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| Determination of reasons for voluntary withdrawal of a listed drug.
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| Removal of a drug product from the list.
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| Adulteration and misbranding of an approved drug.
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Subpart E--HEARING PROCEDURES FOR NEW DRUGS
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| Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
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Subpart F--[RESERVED]
Subpart G--MISCELLANEOUS PROVISIONS
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| Imports and exports of new drugs.
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| Availability for public disclosure of data and information in an application or abbreviated application.
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| Addresses for applications and abbreviated applications.
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Subpart H--ACCELERATED APPROVAL OF NEW DRUGS FOR SERIOUS OR LIFE-THREATENING ILLNESSES
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| Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
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| Approval with restrictions to assure safe use.
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| Postmarketing safety reporting.
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| Termination of requirements.
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Subpart I--APPROVAL OF NEW DRUGS WHEN HUMAN EFFICACY STUDIES ARE NOT ETHICAL OR FEASIBLE
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| Approval based on evidence of effectiveness from studies in animals.
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| Postmarketing safety reporting.
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| Termination of requirements.
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