21 CFR 312.50 - General responsibilities of sponsors.

Status message

There is 1 rule appearing in the Federal Register for 21 CFR Part 312. View below or at eCFR (GPOAccess)
prev | next
§ 312.50 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.

Title 21 published on 2015-04-01.

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.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

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 2015-04-01

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

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271