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Regulations last checked for updates: Jun 14, 2025
Title 21 - Food and Drugs last revised: Jun 03, 2025
All Titles
Title 21
Chapter I
Part 314
Subpart D - 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- Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
355
a,
355
f,
356
,
356
a,
356
b,
356
c,
356
e,
360cc
,
371
,
374
,
379e
,
379k
source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted.
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