21 CFR 314, Subpart D - FDA Action on Applications and Abbreviated Applications
- § 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— Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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.
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 314 after this date.
