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CFR › Title 21 › Chapter I › Subchapter A › Part 50 › Subpart D › Section 50.50

21 CFR 50.50 - IRB duties.

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§ 50.50
IRB duties.
In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51, § 50.52, or § 50.53 and the conditions of all other applicable sections of this subpart D.

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.

  • 2013-02-26; vol. 78 # 38 - Tuesday, February 26, 2013
    1. 78 FR 12937 - Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective March 28, 2013.
      21 CFR Parts 50 and 56

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

§ 321 - Definitions; generally

§ 343 - Misbranded food

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 348 - Food additives

§ 350a - Infant formulas

§ 350b - New dietary ingredients

§ 352 - Misbranded drugs and devices

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

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

§ 360f - Banned devices

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 381 - Imports and exports

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 241 - Research and investigations generally

§ 262 - Regulation of biological products

§ 263b - Certification of mammography facilities

42 USC § 259 to 261a - Repealed.

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 50 after this date.

  • 2013-02-26; vol. 78 # 38 - Tuesday, February 26, 2013
    1. 78 FR 12937 - Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective March 28, 2013.
      21 CFR Parts 50 and 56