Which of the following organizations reviews Investigational New Drug Applications?
TJC
USP
FDA
ISMP
FDA
Rationale: The Food and Drug Administration (FDA) reviews Investigational New Drug Applications. An Investigator IND is submitted by a physician who initiates and conducts a new drug investigation, and under whose immediate direction the drug is administered or dispensed. There are also emergency use and experimental treatment applications.
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If a pharmacy technician writes the DAW code on a prescription in error, what could result?
A) A life-threatening medication error B) The patient could be overcharged for a generic medication. C) The pharmacy technician could be charged with fraud. D) The DEA could revoke the pharmacy's license to practice.
Under the Civil Monetary Penalties Law (CMPL), physicians who pay or accept kickbacks face penalties of up to:
A) $50,000 per kickback plus three times the amount of the remuneration. B) $250,000 per kickback. C) $100,000 per kickback plus three times the amount of remuneration. D) $500 set fine plus up to 5 years in prison.
Which of the following immunoassays produces a fluorescent molecule, 4-methylumbelliferone that serves as the detector compound?
A. Microparticulate enzyme immunoassay B. Substrate labeled fluorescent immunoassay C. Enzyme multiplied immunoassay D. Fluorescent polarization immunoassay
What are the goals of each of the four phases of DTM?
What will be an ideal response?