BCMAS FINAL EXAM STUDY
GUIDE 2025/2026 ACCURATE
QUESTIONS AND CORRECT
DETAILED ANSWERS WITH
RATIONALES || 100%
GUARANTEED PASS <RECENT
VERSION>
Medical Device User Fees Amendment of 2012 - 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. - ANSWER True
The risk associated with this type of drug may not be well understood. -
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? - 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? - ANSWER 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. - ANSWER False
Which are considered key items the FDA will contemplate when
deciding on whether REMS is needed? - ANSWER 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? - ANSWER confounding
T/F: Medical writers should avoid addressing the public's questions to
prevent the spread of health misinformation. - ANSWER False
Most commonly used study design: - ANSWER parallel
Under what conditions can a pharma company provide financial support
for conferences and CME? - 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: - 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: - ANSWER advisors
in vitro diagnostic test - example - ANSWER microbiology culture
in vitro versus in vivo - ANSWER in vitro describes something "in
glass" such as a test tube or petri dish
in vivo is "within a living organism"
Fundamental requirement for ongoing risk evaluations of REMS: -
ANSWER timely data collection
Best practice and ethical standards for reporting research published in
medical journals - ANSWER ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical
interventions taken by HCPs prior to using the drug. - ANSWER True
, Combination product applicant(s) - 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. - ANSWER
False
Export challenge of a medical device company: - ANSWER Violation of
intellectual property rights
Purposes of IIS - 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 - 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
FDA clearance for medical devices - 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 - ANSWER DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with
MA. - 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? -
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? - ANSWER Document the
agreement
The process of internal cooperation, coordination, and common
standards across the global pharmaceutical industry is referred to as: -
ANSWER Harmonization
5-step process to respond to a medical information question - ANSWER
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). - ANSWER False
Who is required to submit a periodic safety update report? - ANSWER
Marketing authorization holders (MAHs) according to the data points
outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies. - ANSWER True
What are some of the ways that companies can benefit from non-
mandated Post-Marketing studies? - ANSWER 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?
- ANSWER 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? - ANSWER Yes, it would be unethical
GUIDE 2025/2026 ACCURATE
QUESTIONS AND CORRECT
DETAILED ANSWERS WITH
RATIONALES || 100%
GUARANTEED PASS <RECENT
VERSION>
Medical Device User Fees Amendment of 2012 - 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. - ANSWER True
The risk associated with this type of drug may not be well understood. -
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? - 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? - ANSWER 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. - ANSWER False
Which are considered key items the FDA will contemplate when
deciding on whether REMS is needed? - ANSWER 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? - ANSWER confounding
T/F: Medical writers should avoid addressing the public's questions to
prevent the spread of health misinformation. - ANSWER False
Most commonly used study design: - ANSWER parallel
Under what conditions can a pharma company provide financial support
for conferences and CME? - 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: - 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: - ANSWER advisors
in vitro diagnostic test - example - ANSWER microbiology culture
in vitro versus in vivo - ANSWER in vitro describes something "in
glass" such as a test tube or petri dish
in vivo is "within a living organism"
Fundamental requirement for ongoing risk evaluations of REMS: -
ANSWER timely data collection
Best practice and ethical standards for reporting research published in
medical journals - ANSWER ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical
interventions taken by HCPs prior to using the drug. - ANSWER True
, Combination product applicant(s) - 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. - ANSWER
False
Export challenge of a medical device company: - ANSWER Violation of
intellectual property rights
Purposes of IIS - 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 - 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
FDA clearance for medical devices - 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 - ANSWER DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with
MA. - 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? -
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? - ANSWER Document the
agreement
The process of internal cooperation, coordination, and common
standards across the global pharmaceutical industry is referred to as: -
ANSWER Harmonization
5-step process to respond to a medical information question - ANSWER
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). - ANSWER False
Who is required to submit a periodic safety update report? - ANSWER
Marketing authorization holders (MAHs) according to the data points
outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies. - ANSWER True
What are some of the ways that companies can benefit from non-
mandated Post-Marketing studies? - ANSWER 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?
- ANSWER 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? - ANSWER Yes, it would be unethical
