[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.1]
[Page 279]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 50 PROTECTION OF HUMAN SUBJECTS--Table of Contents
Subpart A General Provisions
Sec. 50.1 Scope.
(a) This part applies to all clinical investigations regulated by
the Food and Drug Administration under sections 505(i) and 520(g) of the
Federal Food, Drug, and Cosmetic Act, as well as clinical investigations
that support applications for research or marketing permits for products
regulated by the Food and Drug Administration, including foods,
including dietary supplements, that bear a nutrient content claim or a
health claim, infant formulas, food and color additives, drugs for human
use, medical devices for human use, biological products for human use,
and electronic products. Additional specific obligations and commitments
of, and standards of conduct for, persons who sponsor or monitor
clinical investigations involving particular test articles may also be
found in other parts (e.g., parts 312 and 812). Compliance with these
parts is intended to protect the rights and safety of subjects involved
in investigations filed with the Food and Drug Administration pursuant
to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-
520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and
sections 351 and 354-360F of the Public Health Service Act.
(b) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
[45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27, 1981, as amended at 63
FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24,
2001]
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