Source: https://www.law.cornell.edu/cfr/text/21/part-314/subpart-D
Timestamp: 2015-03-30 04:41:51
Document Index: 395703427

Matched Legal Cases: ['art 314', 'art 314', 'art 314', 'art 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', 'art 314']

21 CFR Part 314, Subpart D - FDA Action on Applications and Abbreviated Applications | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 314 › Subpart D 21 CFR Part 314, Subpart D - FDA Action on Applications and Abbreviated Applications
There are 4 Updates appearing in the Federal Register for 21 CFR Part 314. View below or at eCFR (GPOAccess)
§ 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— Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.
50 FR 7493, Feb. 22, 1985, unless otherwise noted. Redesignated at 57 FR 17983, Apr. 28, 1992.
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 314 after this date.2015-02-18; vol. 80 # 32 - Wednesday, February 18, 201580 FR 8577 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period