RGA 6101 NEU New Drug Development Essentials & Oncology Products Exam Practice
Description
1. Your company has submitted your IND for your oncology product to CDER.
How long must you wait before starting your clinical trial? (5 points)
2. Your company has an active IND and is testing its product in patients with
Multiple Sclerosis (MS). During the clinical trial, your Chief Medical
Officer notes that a patient with MS has also been diagnosed with cancer,
but the cancer has stabilized since the patient started the clinical trial. Your
development team decides they would like to pursue using the product to
treat cancer, please explain the steps they should take to open a study with
the same drug in cancer patients? (15 points)
3. Your company decides to submit an IND for a drug-device combination
product to CBER. Summarize what information should be included with the
application and what division at the FDA decides the primary mode of
action for the combination product? (10 points)
4. Provide an example of when you would need to submit an amendment to
your IND? (10 points)
5. What is a IND Annual report and when is the due date? (5 points)
6. What is a serious adverse event and provide an example from the product
you researched for assignment 1? (10 points)
7. What are the benefits of receiving orphan drug designation for your product?
(10 points)
8. List the phases of the Food and Drug Administrations drug approval
process and identify the key characteristics of each phase. (15 points)
9. Describe the purpose of non-clinical drug development (10 points)
10.Explain the difference between a biologic, drug, and vaccine (10 points)
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