ACMA BCMAS Test with All Correct & 100% Verified
Answers| Guaranteed to Pass
What phase does Medical Information usually provide data-driven, targeted, and fair-balanced drug
information for Health Care Professionals (HCPs)? ✔Correct Answer-Phase III
What type of approaches are included in the Drug Discovery Stage? Select all that apply ✔Correct
Answer-Serendipitous approaches
Conventional approaches
Rational approaches
What is an example of a marketed product SRD? ✔Correct Answer-Renal/Hepatic Impairment
Which of the following is true regarding pharmacogenomics? ✔Correct Answer-Enables novel
drugs to be approved
Ian, a Medical Information Specialist, is using a drug manual to write a formal response to a Medical
Information question. What type of level of evidence is this? ✔Correct Answer-Tertiary
What is the difference between Post-Marketing Requirements (PMRs) and Post-Marketing
Commitments (PMCs). Select all that apply ✔Correct Answer-Data from PMRs must be reported to
the FDA.
PMRs are FDA Mandated, while PMCs are not
What is the primary goal of medical affairs? ✔Correct Answer-Objectively present data that may
provide evidence to support the current indication or indications that are "off label
A company designed a new medical device for dental procedures. What does the company need to
do related to FDA registration? Choose all that apply. ✔Correct Answer-The FDA registration must
include the device class and performance standards.
The company must follow all requirements under 21 CFR 872.
The company registers with the FDA once the device is cleared or approved for sale or distribution.
Which are considered key items the FDA will contemplate when deciding on whether REMS is
needed? Select all that apply ✔Correct Answer-Seriousness of side effects
Seriousness of the disease
Benefit of the drug
TRUE/FALSE Study participants serve as their own control in crossover study designs. ✔Correct
Answer-TRUE
Which of the following was used as an obesity treatment and advertised on the radio without
including adverse effects of tachycardia and insomnia? ✔Correct Answer-Marmola
What section of Title 21 of the Code of Federal Regulations (21 CFR) provides the procedures for
performance standards development? ✔Correct Answer-21 CFR 861
TRUE/FALSE Advisory boards are a must have function in a company. ✔Correct Answer-FALSE
Answers| Guaranteed to Pass
What phase does Medical Information usually provide data-driven, targeted, and fair-balanced drug
information for Health Care Professionals (HCPs)? ✔Correct Answer-Phase III
What type of approaches are included in the Drug Discovery Stage? Select all that apply ✔Correct
Answer-Serendipitous approaches
Conventional approaches
Rational approaches
What is an example of a marketed product SRD? ✔Correct Answer-Renal/Hepatic Impairment
Which of the following is true regarding pharmacogenomics? ✔Correct Answer-Enables novel
drugs to be approved
Ian, a Medical Information Specialist, is using a drug manual to write a formal response to a Medical
Information question. What type of level of evidence is this? ✔Correct Answer-Tertiary
What is the difference between Post-Marketing Requirements (PMRs) and Post-Marketing
Commitments (PMCs). Select all that apply ✔Correct Answer-Data from PMRs must be reported to
the FDA.
PMRs are FDA Mandated, while PMCs are not
What is the primary goal of medical affairs? ✔Correct Answer-Objectively present data that may
provide evidence to support the current indication or indications that are "off label
A company designed a new medical device for dental procedures. What does the company need to
do related to FDA registration? Choose all that apply. ✔Correct Answer-The FDA registration must
include the device class and performance standards.
The company must follow all requirements under 21 CFR 872.
The company registers with the FDA once the device is cleared or approved for sale or distribution.
Which are considered key items the FDA will contemplate when deciding on whether REMS is
needed? Select all that apply ✔Correct Answer-Seriousness of side effects
Seriousness of the disease
Benefit of the drug
TRUE/FALSE Study participants serve as their own control in crossover study designs. ✔Correct
Answer-TRUE
Which of the following was used as an obesity treatment and advertised on the radio without
including adverse effects of tachycardia and insomnia? ✔Correct Answer-Marmola
What section of Title 21 of the Code of Federal Regulations (21 CFR) provides the procedures for
performance standards development? ✔Correct Answer-21 CFR 861
TRUE/FALSE Advisory boards are a must have function in a company. ✔Correct Answer-FALSE
