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Drug Research

Conducting Research that Exposes Humans to Drugs, Biologics, Chemicals, or any Other Non-Food Substance

Exposing humans to any drugs, biological agents, chemicals, or any other non-food substance in support of research typically makes the research subject to Food & Drug Agency (FDA) regulations. As a result researchers must comply with additional FDA requirements before beginning the research. Different requirements apply depending on the prior approval status of the agent, how it is being used, the subject population being used, the affect on the risk/benefit ratio associated with the use of the drug, if the study is meant to support a new indication, etc. The following table outlines the primary different types of research and what if anything must be done to comply with FDA regulations.

FDA Requirement by Type of research

Investigational new drug (no prior FDA approval)
IND required – FDA must be contacted
FDA approved/marketed drug used in accordance with package insert, approved indications, approved routes of administration, and/or approved subject populations (prior FDA approval) in a clinical investigation
No IND required
FDA approved/marketed drug used in a manner not previously approved -new indications, different route, different patient/subject population – in support of clinical research, regardless of whether the drug is the central object of the research
FDA must be contacted and investigator must either obtain an (a) IND, or (b) official written determination from the FDA that an IND is not required.
FDA approved/marketed drug used in a research protocol that increases the risk (or decreases the acceptability of risk) to the subject population engaged in the clinical investigation.
FDA must be contacted and investigator must either obtain an (a) IND, or (b) official written determination from the FDA that an IND is not required.
Any other chemical, biologic, or non-food item administered to subjects in support of a clinical investigation, regardless of whether the item is the central object of the research.
FDA must be contacted and investigator must either obtain an (a) IND, or (b) official written determination from the FDA that an IND is not required.

Non-FDA regulated chemicals, including both substances given to induce a physiologic effect and substances that serve as markers or tracers, regardless of whether the item is the central object of research

If a substance to be used in research is not manufactured specifically for use in humans and is not listed in the U.S. Pharmacopeia as intended for use in humans or is not subject to FDA oversight, the IRB protocol must contain the following information pertaining to the substance:
  • A review, based on the published literature, of the mechanism of action,
    potential risks, and accumulated experience with the use of the substance.
    If no animal or human safety data exists, the investigator must present
    safety data from a scaled dose test. Generally, a 500x scaled dose study
    in mice or rats will meet this requirement, but other model systems may
    be used depending upon the nature of the substance to be tested.
  • A statement, based on appropriate calculations, as to whether the substance
    will be administered in an amount that would be expected to have a pharmacologic
    effect. An estimate should be provided of the size of the dose to be administered
    relative to the total physiologic pool of the substance, in cases where
    tracers are used that are analogs of naturally occurring molecules. Most
    commonly this would be stated as a percentage of the total pool.
  • A statement of the source (manufacturer) and whether the substance is
    synthetic or purified from biological sources.
  • Documentation of the purity of the substance to be administered. The preferred
    form of documentation is a Certificate of Analysis from an analytical laboratory.
    As a general rule, if the substance contains impurities, the nature of
    these impurities must be known and stated. Purity may be documented by
    standard methods such as mass spectroscopy and liquid chromatography. If
    a commercial laboratory is used, documentation should be provided that
    the laboratory uses FDA Good Laboratory Practice (GLP) methods. If assays
    of purity are performed by a noncommercial laboratory, the methods should
    be USP standard, and the appropriate USP methodology reference provided.
  • Documentation of the sterility and pyrogen-free characteristics of the
    specific batch(es) to be used in the research. The methods used in this
    determination should be included in the Research Plan, and follow USP methodologies,
    and/or be performed by a GLP laboratory.
  • Documentation, from published literature or specific testing (preferably
    using the same method as noted in c.), of the chemical stability of the
    substance.
  • A description of the formulation of the substance, including the physical
    description of the substance as received from the manufacturer, what solution
    the substance is dissolved in for administration, how it will be administered,
    and its expected toxicities.
  • For research involving radioactive isotopes, a separate application to
    the appropriate Radioactive Drug Research Committee (RDRC) – either VA
    or UCSD–is required. The RDRC will review the proposed use under criteria
    listed in federal regulation 21CFR361.1 and report its decision to the
    IRB. These criteria include both pharmacologic and radiation dose limits,
    and an assessment of whether the radiation exposure is justified on a risk-benefit
    basis.

FDA Office: Center for Drug Evaluation and Research (CDER)

Contact the FDA: (301) 827-4573 or 1-888-INFOFDA (463-6332)
IND/NDA General Information/Forms (301) 827-4573
Personnel list: http://www.fda.gov/cder/directories/keyoffic.pdf
Reference guide: http://www.fda.gov/cder/directories/reference_guide.htm
IND information: http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

FDA Regulations: 51 CFR 312 Subchapter D- Drugs for Human Use

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

Biopharmaceutical Development Program

You may go to the following link and request the “Sponsor’s Guide to Regulatory Submissions for an Investigational New Drug” which provides useful information about what is required to obtain IND approval for new drugs (no prior FDA approval).

NCI at Frederick

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