21 CFR 312.88 - Safeguards for patient safety.

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§ 312.88 Safeguards for patient safety.

All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent ( part 50 of this chapter) and institutional review boards ( part 56 of this chapter). These safeguards further include the review of animal studies prior to initial human testing (§ 312.23), and the monitoring of adverse drug experiences through the requirements of IND safety reports (§ 312.32), safety update reports during agency review of a marketing application ( § 314.50 of this chapter), and postmarketing adverse reaction reporting ( § 314.80 of this chapter).

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

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 312 after this date.

  • 2017-06-21; vol. 82 # 118 - Wednesday, June 21, 2017
    1. 82 FR 28277 - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11—Questions and Answers; Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; notification of availability.
      Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017.
      21 CFR Parts 11, 312, and 812
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