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NUR909 Module 1 Questions And 100% Correct Answers
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NUR909 Module 1 Questions And 100% Correct Answers...
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NUR909 Module 1 Questions And 100% Correct AnswersDoes the FDA regulate over-the-counter medications along with prescription
medications? Yes
Is FDA review & approval required for COMPOUNDED drugs before they are marketed &
released? No
-If compounded, the FDA has already reviewed the two drugs that make up the
compound
Is FDA review & approval required for NONCOMPOUNDED drugs before they are
marketed & released? Yes
-Because they are new
Does FDA have the authority to review dietary products for safety & effectiveness
before they are marketed? -Answer No
-Manufacturers & distributors are responsible for making sure their products are safe
BEFORE they go to market
-Only have to notify FDA if a NEW ingredient is included
Can a manufacturing company make claims that their supplement "prevents obesity?"
-Answer No
Supplements are NOT allowed to be advertised to treat, diagnose, prevent or cure
diseases
, Must you report adverse events and medical product/device problems to the FDA? Yes
-Medication, supplements, & devices
-Part of the device-user facility reporting requirements
-See MedWatch form
Why is the Drug Amendments Act of 1962 significant? It is the first to require
demonstration of effectiveness prior to marketing
-Is it safe & effective before we market it to people & what is the benefit
This helps realize that the evaluation of safety also needs to account for benefit
Consequently, over 1,000 prescription drugs were subject to a label change or
withdrawal from the market
Clinical Trials: Review Phases 0-IV - Solution
What phase of a trial determines the dose or dose range of a new drug? - Solution Phase
I
What phase compares the new drug or treatment with current established treatments? -
Answer Phase III
Studies in this phase involve randomization & blind-testing - Answer Phase III
Which phase of clinical testing occurs after the drug has been approved by the FDA? -
Answer Phase IV
What phase enrolls the largest number of patients or study participants? - Answer
Phase IV
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