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CFR › Title 21 › Chapter I › Subchapter D › Part 312 › Subpart A › Section 312.1

21 CFR 312.1 - Scope.

There is 1 rule appearing in the Federal Register for 21 CFR 312. Select the tab below to view, or View eCFR (GPOAccess)
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§ 312.1
Scope.
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
(b) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2012-04-30; vol. 77 # 83 - Monday, April 30, 2012
    1. 77 FR 25353 - Disqualification of a Clinical Investigator
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 30, 2012.
      21 CFR Parts 16, 312, 511, and 812

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 Code
USC : Title 21 - FOOD AND DRUGS

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 360bbb - Expanded access to unapproved therapies and diagnostics

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 312 after this date.

  • 2012-04-30; vol. 77 # 83 - Monday, April 30, 2012
    1. 77 FR 25353 - Disqualification of a Clinical Investigator
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 30, 2012.
      21 CFR Parts 16, 312, 511, and 812