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)
Which of the following is a fundamental requirement for ongoing risk evaluations of REMS? - Timely
data collection
Which of the items listed below would be an appropriate educational gift that an MSL could give to an
HCP? - Educational items that could be used in a patient examination room, such as anatomical models
In the equivalence trial, the _________ hypothesis states that a difference of at least Δ exists (where Δ is
an interval), and the aim of the trial is to refute this in favor of the alternative hypothesis that no
difference exists. - null
Under what conditions may a company use prescriber data? Check all that apply - -Use data to track
adverse events of marketed prescription drugs
-Use data to focus marketing activities towards HCPs who would most likely benefit from the drug
information.
-Use data with all information related to patient identity omitted
-Only use data if a physician has NOT made a request that their data not be made available to sales
representatives
What are the most common discount rates? - 3% to 5%
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? - Risk of acute pancreatitis and the potential risk of
medullary thyroid carcinoma
In what year were the first GPP guidelines published? - 2003
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