Source: http://www4.law.cornell.edu/cfr/text/21/314/subpart-B
Timestamp: 2013-12-11 10:03:11
Document Index: 475828437

Matched Legal Cases: ['art 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 331', '§ 321', '§ 331', '§ 351', '§ 352', '§ 353', '§ 355', '§ 356', '§ 356', '§ 356', '§ 356', '§ 371', '§ 374', '§ 379', 'arts 201']

21 CFR 314, Subpart B - Applications | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 314 › Subpart B	prev | next
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 2012-04-01no 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.United States CodeUSC : Title 15 - COMMERCE AND TRADE§ 331 to 374 - Omitted
USC : Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 331 - Prohibited acts§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 353 - Exemptions and consideration for certain drugs, devices, and biological products§ 355 - New drugs§ 356 - Fast track products§ 356a - Manufacturing changes§ 356b - Reports of postmarketing studies§ 356c - Discontinuance of life saving product§ 371 - Regulations and hearings§ 374 - Inspection§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
Title 21 published on 2012-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 314 after this date.2013-02-06; vol. 78 # 25 - Wednesday, February 6, 201378 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative; Request for Comments and Information
typeregulations.gov FR Doc.2013-02528 RIN Docket No.FDA-2013-N-0059 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of an initiative; request for comments and information. Submit either electronic or written comments by March 8, 2013. 21 CFR Parts 201, 314, and 601 SummaryThe Food and Drug Administration (FDA) is announcing the establishment of a docket to receive comments on the proposed implementation of FDA&apos;s Prescription Drug Labeling Improvement and Enhancement Initiative and on a proposed pilot project relating to the voluntary conversion of labeling to the “Physician Labeling Rule (PLR)” format described in the 2006 FDA final rule, “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” The purpose of the initiative and the pilot project is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling. FDA is seeking public comment on this initiative, and the pilot project, particularly from stakeholders who develop and use prescription drug labeling. Comments received from stakeholders will assist the Agency in identifying and addressing feasibility and implementation issues associated with this initiative.
Dual Use Item