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Learning Objectives

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After completing this chapter, the reader will be able to

  • List the major legislative acts that led to the current system of drug evaluation, approval, and regulation used in the United States.

  • List the steps in the drug approval process.

  • List the components of an investigational new drug (IND) application.

  • Recognize the difference between a commercial IND, treatment IND, an emergency use IND, and an individual investigator IND.

  • Define orphan drug status and list the advantages of classifying a drug as an orphan drug.

  • List all of the requirements (as specified by the Office of Human Research Protections [OHRP]) for an Institutional Review Board (IRB).

  • Prepare appropriate protocol assessments for use by the IRB or other review committees when they evaluate new human subject protocols.

  • Describe the type of support that is necessary for clinical research, including (but not limited to):

    1. ordering drug supplies for ongoing clinical trials;

    2. maintaining drug accountability records as required by the Food and Drug Administration (FDA);

    3. preparing drug and protocol data sheets for use by health care personnel in the hospital;

    4. preparing pharmacy budgets for sponsored clinical research;

    5. aiding investigators in designing and conducting clinical trials in their institution;

    6. assisting investigators in initiating and conducting clinical trials (including emergency use INDs).

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Key Concepts

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  • 1 The Food and Drug Administration (FDA) is the federal agency that decides which drugs, biologics, and medical devices are safe and efficacious, determinations upon which the agency decides if a product can be marketed in the United States.

  • 2 In addition to review by the FDA, research protocols are also reviewed for ethical appropriateness by IRBs.

  • 3 The drug approval process in the United States is standardized by FDA review. It consists of preclinical testing and Phase I through IV of clinical testing.

  • 4 The investigational new drug (IND) application is the application by the study sponsor to the FDA to begin clinical trials in humans.

  • 5 The IND should be amended as necessary. The four types of documents used to amend the IND include:

    1. Protocol amendments

    2. Information amendments

    3. IND safety reports

    4. IND annual reports

  • 6 After sufficient evidence is obtained regarding the drug's safety and effectiveness, the sponsor will submit a new drug application/biologics licensing application to the FDA requesting approval of the agent for marketing.

  • 7 The FDA allows the manufacturer to charge for an investigational drug under certain conditions.

  • 8 An orphan drug is one that is used for the treatment of a rare disease, affecting fewer than 200,000 people in the United States, or one that will not generate enough revenue to justify the cost of research and development.

  • 9 Drug accountability records are mandated by law. They can be computerized or in paper form. Necessary components include:

    1. Transaction date

    2. Transaction type

    3. The receiving party (for patient dispensing this should include patient initials/identifying number)

    4. The dose/number of units dispensed/received

    5. The lot number dispensed/received

    6. The initials of the person who performed the ...

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