RAC DRUGS QUESTIONS AND
ANSWERS | LATEST UPDATE |
2024/2025 | 100% PASS
What is the purpose of the Drug Enforcement Administration (DEA) in drug regulation?
✔✔The DEA regulates and enforces the controlled substances laws and regulations to prevent
drug abuse and trafficking.
What are the phases of clinical trials for new drugs?
✔✔Clinical trials typically consist of three phases: Phase I (safety), Phase II (efficacy), and
Phase III (confirmatory trials).
What does the term "orphan drug" refer to?
✔✔An orphan drug is a medication developed to treat rare diseases, affecting fewer than
200,000 people in the U.S.
What is the significance of the FDA's Drug Approval Process?
✔✔The FDA's Drug Approval Process ensures that new drugs are safe and effective for public
use before they can be marketed.
1
, What is a generic drug?
✔✔A generic drug is a medication that is chemically identical to a brand-name drug but
marketed without the brand name, usually at a lower price.
What does "post-marketing surveillance" entail?
✔✔Post-marketing surveillance involves monitoring the safety and efficacy of a drug after it has
been approved and is available to the public.
What is the role of the Investigational New Drug (IND) application?
✔✔The IND application allows a pharmaceutical company to start clinical trials on a new drug
in humans.
What are biologics?
✔✔Biologics are products derived from living organisms, such as vaccines, blood components,
and gene therapies, used for diagnosis or treatment.
What is the meaning of "adverse drug reaction"?
✔✔An adverse drug reaction is an unwanted or harmful reaction experienced after the
administration of a drug.
2
ANSWERS | LATEST UPDATE |
2024/2025 | 100% PASS
What is the purpose of the Drug Enforcement Administration (DEA) in drug regulation?
✔✔The DEA regulates and enforces the controlled substances laws and regulations to prevent
drug abuse and trafficking.
What are the phases of clinical trials for new drugs?
✔✔Clinical trials typically consist of three phases: Phase I (safety), Phase II (efficacy), and
Phase III (confirmatory trials).
What does the term "orphan drug" refer to?
✔✔An orphan drug is a medication developed to treat rare diseases, affecting fewer than
200,000 people in the U.S.
What is the significance of the FDA's Drug Approval Process?
✔✔The FDA's Drug Approval Process ensures that new drugs are safe and effective for public
use before they can be marketed.
1
, What is a generic drug?
✔✔A generic drug is a medication that is chemically identical to a brand-name drug but
marketed without the brand name, usually at a lower price.
What does "post-marketing surveillance" entail?
✔✔Post-marketing surveillance involves monitoring the safety and efficacy of a drug after it has
been approved and is available to the public.
What is the role of the Investigational New Drug (IND) application?
✔✔The IND application allows a pharmaceutical company to start clinical trials on a new drug
in humans.
What are biologics?
✔✔Biologics are products derived from living organisms, such as vaccines, blood components,
and gene therapies, used for diagnosis or treatment.
What is the meaning of "adverse drug reaction"?
✔✔An adverse drug reaction is an unwanted or harmful reaction experienced after the
administration of a drug.
2
