BCMAS EXAM SCRIPT UPDATED QUESTIONS AND
ANSWERS SURE A+
✔✔When first working on a publication, what should authors do to identify their rights,
roles, and responsibilities? - ✔✔Document the agreement
✔✔The process of internal cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as: - ✔✔Harmonization
✔✔5-step process to respond to a medical information question - ✔✔1) Determine who
the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
4) Choose the best source
5) Assess the information source and answer the question
✔✔T/f: SRDs are prepared only for HCPs in response to questions about product(s). -
✔✔False
✔✔Who is required to submit a periodic safety update report? - ✔✔Marketing
authorization holders (MAHs) according to the data points outlined in the EURD list.
✔✔T/F: Surveys are classified as cross-sectional studies. - ✔✔True
✔✔Medical Device User Fees Amendment of 2012 - ✔✔Allows the FDA to collect user
fees for pre-market approvals to improve the overall review process
✔✔T/F: An abbreviated new drug application (ANDA) is submitted to the FDA for
generic drugs. - ✔✔True
✔✔The risk associated with this type of drug may not be well understood. - ✔✔New
drug substance
✔✔Amber is an MSL and receives a question from a physician about a medication
indication that is not FDA approved. Which of the following is true? - ✔✔This is an
unsolicited request.
This information is off-label.
✔✔A Pharma company is looking to begin the development of a new drug. Why would
the company consult an advisory board? - ✔✔To provide their opinion on the research
and development of the drug
,✔✔T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review
Board (IRB)) subpart B, there needs to be a minimum of 2 members in the IRB. -
✔✔False
✔✔Which are considered key items the FDA will contemplate when deciding on
whether REMS is needed? - ✔✔Seriousness of the disease
Seriousness of side effects
Benefit of the drug
✔✔In research which of the terms below describes a distortion caused by other
variables to both exposure and outcome? - ✔✔confounding
✔✔T/F: Medical writers should avoid addressing the public's questions to prevent the
spread of health misinformation. - ✔✔False
✔✔What are some of the ways that companies can benefit from non-mandated Post-
Marketing studies? - ✔✔Detect any cost-benefits associated with the drugs
Compare a drug with other currently available medications in the same class
Detect other uses of the drugs
✔✔Approximately how many slides should a 15 minute presentation include? - ✔✔7-8
✔✔Dr. Simpson, a neurologist, occasionally participates on an advisory board for
Lightning Pharmaceuticals. Dr. Simpson has also just become a member of a national
committee that makes recommendations for clinical guidelines and formulary decisions.
Is Dr. Simpson required to disclose her relationship with Lightning Pharmaceuticals to
the national committee she is a member of? - ✔✔Yes, it would be unethical and
potentially a conflict of interest if she does not disclose the relationship.
✔✔Which statement is not true about promotional materials?
A) Promotional materials must present an unbiased picture of the drug, including its
risks and benefits
B) All MSLs should offer the same promotional materials provided by the company and
not "make their own"
C) Promotional materials can include off-label drug information
D) Promotional materials must adhere to FDA requirements and label information only -
✔✔C) Promotional materials can include off-label drug information
✔✔T/F: The regulatory requirements for drug products include much tighter controls
over the manufacturing process than for medical devices. - ✔✔True
, ✔✔"The study of variations in DNA and RNA characteristics as related to drug
response" - ✔✔Pharmacogenomics
✔✔T/F: A kick-off call is a call in which the pharma company brings in the KOL
(physician, nurse practitioner, pharmacist, etc.) who will collaborate in developing the
publication. - ✔✔True
✔✔T/F: Misuse of funding resources is a potential disadvantage of IIS - ✔✔True
✔✔What is the scientific platform? - ✔✔An important guide in developing the publication
plan for the product
✔✔Which step of the device development process involves the product launch and
post-market safety monitoring? - ✔✔Step 5
✔✔direct medical costs - ✔✔medically-related costs used directly in providing treatment
✔✔What can be both a challenge for advisory boards and a key element to a board's
success? - ✔✔preparing and planning for a meeting, including the use of an agenda
and meeting moderator
✔✔A company is developing an advisory board for a new medical device, what are two
essential compliance aspects for the company to keep in mind? - ✔✔Board should have
clear learning objectives with meeting materials aligned.
Board should fill a knowledge gap that the company has.
✔✔First step of the process for device development? - ✔✔Device discovery and
concept
✔✔Which is the chief consumer watchdog which assesses new drugs before they hit
the market and continues to monitor safety after they are marketed? - ✔✔Center for
Drug Evaluation and Research (CDER)
✔✔Which drug description would be most likely to meet approval as a generic drug? -
✔✔generic drug is available in the same approved strengths and dosage as the brand-
name drug
✔✔triad between manufacturers, HCPs, and consumers - ✔✔model for the
biopharmaceutical industry where HCPs are the important "middlemen"
✔✔When might someone utilize an RMP/REMS? - ✔✔better identify, characterize, and
minimize any important risk of a drug in its post-approval life
ANSWERS SURE A+
✔✔When first working on a publication, what should authors do to identify their rights,
roles, and responsibilities? - ✔✔Document the agreement
✔✔The process of internal cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as: - ✔✔Harmonization
✔✔5-step process to respond to a medical information question - ✔✔1) Determine who
the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
4) Choose the best source
5) Assess the information source and answer the question
✔✔T/f: SRDs are prepared only for HCPs in response to questions about product(s). -
✔✔False
✔✔Who is required to submit a periodic safety update report? - ✔✔Marketing
authorization holders (MAHs) according to the data points outlined in the EURD list.
✔✔T/F: Surveys are classified as cross-sectional studies. - ✔✔True
✔✔Medical Device User Fees Amendment of 2012 - ✔✔Allows the FDA to collect user
fees for pre-market approvals to improve the overall review process
✔✔T/F: An abbreviated new drug application (ANDA) is submitted to the FDA for
generic drugs. - ✔✔True
✔✔The risk associated with this type of drug may not be well understood. - ✔✔New
drug substance
✔✔Amber is an MSL and receives a question from a physician about a medication
indication that is not FDA approved. Which of the following is true? - ✔✔This is an
unsolicited request.
This information is off-label.
✔✔A Pharma company is looking to begin the development of a new drug. Why would
the company consult an advisory board? - ✔✔To provide their opinion on the research
and development of the drug
,✔✔T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review
Board (IRB)) subpart B, there needs to be a minimum of 2 members in the IRB. -
✔✔False
✔✔Which are considered key items the FDA will contemplate when deciding on
whether REMS is needed? - ✔✔Seriousness of the disease
Seriousness of side effects
Benefit of the drug
✔✔In research which of the terms below describes a distortion caused by other
variables to both exposure and outcome? - ✔✔confounding
✔✔T/F: Medical writers should avoid addressing the public's questions to prevent the
spread of health misinformation. - ✔✔False
✔✔What are some of the ways that companies can benefit from non-mandated Post-
Marketing studies? - ✔✔Detect any cost-benefits associated with the drugs
Compare a drug with other currently available medications in the same class
Detect other uses of the drugs
✔✔Approximately how many slides should a 15 minute presentation include? - ✔✔7-8
✔✔Dr. Simpson, a neurologist, occasionally participates on an advisory board for
Lightning Pharmaceuticals. Dr. Simpson has also just become a member of a national
committee that makes recommendations for clinical guidelines and formulary decisions.
Is Dr. Simpson required to disclose her relationship with Lightning Pharmaceuticals to
the national committee she is a member of? - ✔✔Yes, it would be unethical and
potentially a conflict of interest if she does not disclose the relationship.
✔✔Which statement is not true about promotional materials?
A) Promotional materials must present an unbiased picture of the drug, including its
risks and benefits
B) All MSLs should offer the same promotional materials provided by the company and
not "make their own"
C) Promotional materials can include off-label drug information
D) Promotional materials must adhere to FDA requirements and label information only -
✔✔C) Promotional materials can include off-label drug information
✔✔T/F: The regulatory requirements for drug products include much tighter controls
over the manufacturing process than for medical devices. - ✔✔True
, ✔✔"The study of variations in DNA and RNA characteristics as related to drug
response" - ✔✔Pharmacogenomics
✔✔T/F: A kick-off call is a call in which the pharma company brings in the KOL
(physician, nurse practitioner, pharmacist, etc.) who will collaborate in developing the
publication. - ✔✔True
✔✔T/F: Misuse of funding resources is a potential disadvantage of IIS - ✔✔True
✔✔What is the scientific platform? - ✔✔An important guide in developing the publication
plan for the product
✔✔Which step of the device development process involves the product launch and
post-market safety monitoring? - ✔✔Step 5
✔✔direct medical costs - ✔✔medically-related costs used directly in providing treatment
✔✔What can be both a challenge for advisory boards and a key element to a board's
success? - ✔✔preparing and planning for a meeting, including the use of an agenda
and meeting moderator
✔✔A company is developing an advisory board for a new medical device, what are two
essential compliance aspects for the company to keep in mind? - ✔✔Board should have
clear learning objectives with meeting materials aligned.
Board should fill a knowledge gap that the company has.
✔✔First step of the process for device development? - ✔✔Device discovery and
concept
✔✔Which is the chief consumer watchdog which assesses new drugs before they hit
the market and continues to monitor safety after they are marketed? - ✔✔Center for
Drug Evaluation and Research (CDER)
✔✔Which drug description would be most likely to meet approval as a generic drug? -
✔✔generic drug is available in the same approved strengths and dosage as the brand-
name drug
✔✔triad between manufacturers, HCPs, and consumers - ✔✔model for the
biopharmaceutical industry where HCPs are the important "middlemen"
✔✔When might someone utilize an RMP/REMS? - ✔✔better identify, characterize, and
minimize any important risk of a drug in its post-approval life
