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Title 21

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Editorial codification of the general and permanent rules published in the Federal Register.

Title 21 Food and Drugs Part / Section
Chapter I Food and Drug Administration, Department of Health and Human Services 1 – 1299
Subchapter D Drugs for Human Use 300 – 499
Part 314 Applications for FDA Approval to Market a New Drug 314.1 – 314.650
Subpart D FDA Action on Applications and Abbreviated Applications 314.100 – 314.170
§ 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314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.