FDA Regulations and Drug Safety Quiz
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Questions and Answers

What is the purpose of the 1938 Act mentioned in the text?

  • Prohibiting the distribution and use of harmful drugs like diethylene glycol
  • Ensuring only grandfathered drugs are distributed and used
  • Regulating the distribution and use of new drugs without FDA approval (correct)
  • Making it easier to purchase prescription drugs over the counter

    • What distinction did the Durham-Humphrey Amendment of 1951 introduce?

  • Limitation on the distribution of dangerous drugs like Thalidomide
  • Differentiation between FDA-approved and non-FDA-approved drugs
  • Legal division between prescription and over-the-counter drugs (correct)
  • Categorization of drugs based on their potential side effects

    • What event led to the passing of the Kefauver-Harris Amendments of 1962?

  • Thalidomide-induced birth defects in newborns (correct)
  • A significant increase in drug prices by pharmaceutical companies
  • Misuse of prescription drugs by consumers
  • Discovery of harmful side effects of commonly used drugs

    • What is the significance of an Investigational New Drug (IND) application in drug development?

    <p>It grants permission to conduct clinical trials on a new drug</p> Signup and view all the answers

    Which drug mentioned in the text was associated with severe birth defects like phocomelia?

    <p>Thalidomide</p> Signup and view all the answers

    What is the purpose of a dosage form in drug formulation?

    <p>To ensure safe and convenient delivery of accurate dosage</p> Signup and view all the answers

    Which aspect of drug formulation is related to concealing bitter, salty, or offensive taste or odor of a drug?

    <p>Concealing taste or odor</p> Signup and view all the answers

    What does the term 'dosage regimen' refer to in drug formulation?

    <p>The frequency at which drug doses are given</p> Signup and view all the answers

    In drug formulation, what do dosage instructions typically include?

    <p>Frequency at which the drug doses should be given</p> Signup and view all the answers

    Which factor is NOT a benefit provided by different dosage forms in drug formulation?

    <p>Drug discovery and development timeline</p> Signup and view all the answers

    What is the main purpose of the Kefauver-Harris Amendments of 1962?

    <p>To require drug manufacturers to prove drug safety and effectiveness before FDA approval</p> Signup and view all the answers

    Which act consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens?

    <p>Comprehensive Drug Abuse Prevention and Control Act of 1970</p> Signup and view all the answers

    What is the purpose of an Investigational New Drug (IND) application?

    <p>To provide FDA with enough information to ensure the drug's safety before human testing</p> Signup and view all the answers

    What do the five schedules for drugs subject to abuse refer to?

    <p>Different classifications based on abuse potential</p> Signup and view all the answers

    How did the Thalidomide tragedy impact drug regulation?

    <p>It highlighted the importance of rigorous drug testing before market approval</p> Signup and view all the answers

    What is the role of the Food and Drug Administration (FDA) in the drug development process?

    <p>To ensure the safety and efficacy of new drugs before they can be introduced in interstate commerce</p> Signup and view all the answers

    What is a key requirement for a new drug before it can be legally introduced in interstate commerce?

    <p>Approval by the Code of Federal Regulations (CFR)</p> Signup and view all the answers

    Which of the following is NOT a goal of a drug in drug discovery and design?

    <p>Frequent dosing intervals</p> Signup and view all the answers

    What regulatory requirements are outlined in the Kefauver-Harris Amendments of 1962?

    <p>Additional requirements related to cGMP for finished pharmaceuticals</p> Signup and view all the answers

    What is the purpose of an Investigational New Drug (IND) application?

    <p>To start clinical trials on a new drug in humans</p> Signup and view all the answers

    Study Notes

    History of Drug Regulation

    • The 1938 Act aimed to ensure the safety of drugs before they enter the market.
    • The Durham-Humphrey Amendment of 1951 introduced the distinction between prescription and over-the-counter (OTC) drugs.

    Kefauver-Harris Amendments of 1962

    • The Kefauver-Harris Amendments were passed in response to the thalidomide tragedy, which caused severe birth defects like phocomelia.
    • The main purpose of the Kefauver-Harris Amendments was to ensure the efficacy and safety of drugs before they enter the market.

    Investigational New Drug (IND) Application

    • An IND application is a critical step in drug development, allowing researchers to conduct clinical trials on human subjects.
    • The purpose of an IND application is to gather safety and efficacy data on a new drug.

    Dosage Form and Dosage Regimen

    • A dosage form refers to the physical form of a drug, such as a pill or injection.
    • The purpose of a dosage form is to ensure the safe and effective delivery of a drug to the patient.
    • Dosage instructions typically include information on the route of administration, frequency, and duration of treatment.
    • The dosage regimen refers to the specific schedule of administration of a drug.

    Food and Drug Administration (FDA)

    • The FDA plays a crucial role in the drug development process, overseeing the approval of new drugs.
    • A key requirement for a new drug before it can be legally introduced in interstate commerce is FDA approval.

    Controlled Substances

    • The Comprehensive Drug Abuse Prevention and Control Act of 1970 consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens.
    • The five schedules for drugs subject to abuse refer to the potential for abuse, currently accepted medical use, and safety under medical supervision.

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    Test your knowledge on FDA regulations, drug safety, and grandfathered drugs. Learn about the history of drug regulation in the US and key points related to drug approval processes.

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