Office of Research Investigational Drugs & Devices - Office of Research

Investigational Drugs & Devices

The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives. FDA regulations are not always consistent with DHHS regulations for human subjects protections.

This guidance is meant to assist reseachers in determining if their research requires FDA oversight, and how to comply with the FDA’s requirements, when applicable.

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Requirements

For FDA-regulated research involving investigational drugs and biologics investigators are required to abide by the following:

For more information about conducting FDA regulated research, and additional requirements for Clinical Trials (ICH-GCP) please refer to the Investigator’s Manual (HRP-103).


 

Definitions

A biological product, as defined in section 351(i) of the Public Health Service Act, is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

A cosmetic is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body. . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.

A dietary supplement (as defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994) is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

  • The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
  • Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

A drug:

  • Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
  • Is intended to affect the structure or any function of the body of man or other animals.

Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

A medical device:

  • Is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
  • Is intended to affect the structure or any function of the body of man or other animals.
  • Does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.
  • Is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).


 

Resources

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