BCMAS Final Exam Q&A 2026
Study Guide.
Most commonly used study design:
Correct Answer: parallel
Under what conditions can a pharma company provide
financial support for conferences and CME?
Correct Answer: The grants/contributions are separate
from other company funds
The company has had no control over the selection of
content, faculty, or venue
Not required by ADR reporting:
Correct Answer: careful selection of clinical trial
participants
Required:
-recognition of events
-safety signals are identified against a background of
events
-accurate reporting
Individual board members are known as:
Correct Answer: advisors
in vitro diagnostic test - example
Correct Answer: microbiology culture
in vitro versus in vivo
Correct Answer: in vitro describes something "in glass"
such as a test tube or petri dish
in vivo is "within a living organism"
1
,Fundamental requirement for ongoing risk evaluations of
REMS:
Correct Answer: timely data collection
Best practice and ethical standards for reporting research
published in medical journals
Correct Answer: ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required
medical interventions taken by HCPs prior to using the
drug.
Correct Answer: True
Combination product applicant(s)
Correct Answer: The company that holds the application
for the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS.
Correct Answer: False
Export challenge of a medical device company:
Correct Answer: Violation of intellectual property rights
Purposes of IIS
Correct Answer: develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
Goals of pharmacogenomics
Correct Answer: Individualize therapies based on genetic
differences
Predict individual responses to a drug to decrease
adverse drug reactions
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
2
,FDA clearance for medical devices
Correct Answer: May be given for devices with substantial
equivalence to a known predicate device
Allows the device to be marketed and sold once a Pre-
Market Notification has been submitted
May be issued if the device existed in the market prior to
1976
EBM databases
Correct Answer: DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a
position with MA.
Correct Answer: False
What would cause the FDA to require post-marketing
studies or clinical trials at the time of approval or
afterwards for a new product?
Correct Answer: If the FDA becomes aware of new safety
information from SADR reporting.
When first working on a publication, what should authors
do to identify their rights, roles, and responsibilities?
Correct Answer: Document the agreement
The process of internal cooperation, coordination, and
common standards across the global pharmaceutical
industry is referred to as:
Correct Answer: Harmonization
5-step process to respond to a medical information
question
Correct Answer: 1) Determine who the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
3
, 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).
Correct Answer: False
Who is required to submit a periodic safety update report?
Correct Answer: Marketing authorization holders (MAHs)
according to the data points outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies.
Correct Answer: True
Medical Device User Fees Amendment of 2012
Correct Answer: 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.
Correct Answer: True
The risk associated with this type of drug may not be well
understood.
Correct Answer: 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?
Correct Answer: 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?
4
Study Guide.
Most commonly used study design:
Correct Answer: parallel
Under what conditions can a pharma company provide
financial support for conferences and CME?
Correct Answer: The grants/contributions are separate
from other company funds
The company has had no control over the selection of
content, faculty, or venue
Not required by ADR reporting:
Correct Answer: careful selection of clinical trial
participants
Required:
-recognition of events
-safety signals are identified against a background of
events
-accurate reporting
Individual board members are known as:
Correct Answer: advisors
in vitro diagnostic test - example
Correct Answer: microbiology culture
in vitro versus in vivo
Correct Answer: in vitro describes something "in glass"
such as a test tube or petri dish
in vivo is "within a living organism"
1
,Fundamental requirement for ongoing risk evaluations of
REMS:
Correct Answer: timely data collection
Best practice and ethical standards for reporting research
published in medical journals
Correct Answer: ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required
medical interventions taken by HCPs prior to using the
drug.
Correct Answer: True
Combination product applicant(s)
Correct Answer: The company that holds the application
for the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS.
Correct Answer: False
Export challenge of a medical device company:
Correct Answer: Violation of intellectual property rights
Purposes of IIS
Correct Answer: develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
Goals of pharmacogenomics
Correct Answer: Individualize therapies based on genetic
differences
Predict individual responses to a drug to decrease
adverse drug reactions
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
2
,FDA clearance for medical devices
Correct Answer: May be given for devices with substantial
equivalence to a known predicate device
Allows the device to be marketed and sold once a Pre-
Market Notification has been submitted
May be issued if the device existed in the market prior to
1976
EBM databases
Correct Answer: DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a
position with MA.
Correct Answer: False
What would cause the FDA to require post-marketing
studies or clinical trials at the time of approval or
afterwards for a new product?
Correct Answer: If the FDA becomes aware of new safety
information from SADR reporting.
When first working on a publication, what should authors
do to identify their rights, roles, and responsibilities?
Correct Answer: Document the agreement
The process of internal cooperation, coordination, and
common standards across the global pharmaceutical
industry is referred to as:
Correct Answer: Harmonization
5-step process to respond to a medical information
question
Correct Answer: 1) Determine who the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
3
, 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).
Correct Answer: False
Who is required to submit a periodic safety update report?
Correct Answer: Marketing authorization holders (MAHs)
according to the data points outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies.
Correct Answer: True
Medical Device User Fees Amendment of 2012
Correct Answer: 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.
Correct Answer: True
The risk associated with this type of drug may not be well
understood.
Correct Answer: 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?
Correct Answer: 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?
4
