Exam (elaborations)
BCMAS TEST 4 QUESTIONS AND ANSWERS
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BCMAS TEST 4 QUESTIONS AND ANSWERS
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Name: Score:24 Multiple choice questions
Term 1 of 24
Ryan is applying for an educational grant to implement a naloxone training program for
healthcare professionals. Which of the following is the first step in Ryan's grant process?
30 Days
Pre-award
Post-award
Form Contract
Term 2 of 24
According to the PhRMA code, promotional materials provided to healthcare professionals by,
or on behalf of a company should: Select all that apply.
Educational items that could be used in a patient examination room, such as anatomical
models
Risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma
-be accurate and not misleading
-reflect the balance between risk and benefit
-be consistent with all other FDA requirements governing communication between MSLs
and HCPs
-Using humans outside of the clinical trials
-Using observational pharmacoepidemiological studies
*Using health claims data, electronic medical records and patient/disease registries
Term 3 of 24
True/False The medical affairs team contributes to the product launch by educating the
medical community and customer groups.
True
False
,Term 4 of 24
An innovative drug is also referred to as:
this is an unsolicited request
a brand-name drug.
a generic drug.
a drug in the pre-discovery phase of development.
Term 5 of 24
What are the most common discount rates?
2% to 3%
1% to 2%
5% to 10%
3% to 5%
Term 6 of 24
A physician asks a medical affairs professional about an off-label use of an FDA approved
drug. Which of the following is true?
This is a prohibited request
This is an unsolicited request
This is an official request
Communication
Term 7 of 24
TRUE/FALSE Active surveillance systems are using databases and various statistical techniques
to identify safety signals that require further evaluation.
True
False
, Term 8 of 24
Eve, a Medical Information Specialist, is following the 5-step process to respond to a Medical
Information question. What should they do first?
Determine who the audience is
-be accurate and not misleading
-reflect the balance between risk and benefit
-be consistent with all other FDA requirements governing communication between MSLs
and HCPs
Choose the KOLs/physicians who will serve as authors for different publications
FDA post-market safety monitoring
Term 9 of 24
A patient is taking the drug Bydureon BCise (exenatide extended-release injection) to treat
type 2 diabetes mellitus. When the communication plan is established for this product, what
will the REMS inform healthcare professionals about this drug?
Dosage adjustment guidelines for bydureon bcise
Risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma
Common side effects like headache and nausea
Benefits of regular exercise and healthy diet for diabetes management
Term 10 of 24
A company made a modification to a device that has FDA-established performance standards
for the device and the modification already in place. Which FDA filing type should the
company submit?
Abbreviated 510(k)
Special 510(k)
Traditional 510(k)
Pma
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