Exam (elaborations)
ACMA BCMAS QUESTIONS AND ANSWERS
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ACMA BCMAS QUESTIONS AND ANSWERS
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Name: Score:24 Multiple choice questions
Term 1 of 24
What section of Title 21 of the Code of Federal Regulations (21 CFR) provides the procedures
for performance standards development?
10/30
Phase III
Marmola
21 CFR 861
Term 2 of 24
What is the difference between Post-Marketing Requirements (PMRs) and Post-Marketing
Commitments (PMCs). Select all that apply
-Detect other uses of the drugs
-Compare a drug with other currently available medications in the same class
-Detect any cost-benefits associated with the drugs
Seriousness of side effects
Seriousness of the disease
Benefit of the drug
Objectively present data that may provide evidence to support the current indication or
indications that are "off label
Data from PMRs must be reported to the FDA.
PMRs are FDA Mandated, while PMCs are not
,Term 3 of 24
REMS are designed to address the _________ for different drugs and classes of drugs.
Unique safety measures
-Internal Validity
-External Validity
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.
Sometimes requested by the FDA
Term 4 of 24
What is the primary goal of medical affairs?
Outcomes are assumed to be equivalent
Objectively present data that may provide evidence to support the current indication or
indications that are "off label
It is an adjustment based on forecasting of money that will be spent or saved in future
years
Data from PMRs must be reported to the FDA.
PMRs are FDA Mandated, while PMCs are not
, Term 5 of 24
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.
-Help advance appropriate patient use
-Facilitate communication with third-party payers to effectively control the costs of
products
-Ensure HCPs have the latest and most accurate available data
-Obtain feedback and advice about products through consultation with medical experts
Phase III
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.
Unique safety measures
Term 6 of 24
What are the most important types of validity? Check all that apply.
Convenience Kit or Co-Package
Enables novel drugs to be approved
-Internal Validity
-External Validity
Outcomes are assumed to be equivalent
Term 7 of 24
What is an example of a marketed product SRD?
Renal/Hepatic Impairment
-Internal Validity
-External Validity
Outcomes are assumed to be equivalent
Enables novel drugs to be approved
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