21 CFR 314, Subpart B - Applications
- § 314.50 — Content and format of an application.
- § 314.52 — Notice of certification of invalidity or noninfringement of a patent.
- § 314.53 — Submission of patent information.
- § 314.54 — Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug.
- § 314.55 — Pediatric use information.
- § 314.60 — Amendments to an unapproved application, supplement, or resubmission.
- § 314.65 — Withdrawal by the applicant of an unapproved application.
- § 314.70 — Supplements and other changes to an approved application.
- § 314.71 — Procedures for submission of a supplement to an approved application.
- § 314.72 — Change in ownership of an application.
- § 314.80 — Postmarketing reporting of adverse drug experiences.
- § 314.81 — Other postmarketing reports.
- § 314.90 — Waivers.
- § 314.91 — Obtaining a reduction in the discontinuance notification period.
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.
