Code of Federal Regulations > Title 21 > Chapter I > Part 314 > Subpart D - Subpart D—FDA Action on Applications and Abbreviated Applications

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Dec 08, 2025

§ 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- Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.