RAC 40 QUIZ 5 Review | Latest Update |
2024/2025 | Rated A+
What is the main objective of a regulatory submission?
To obtain approval for a product's marketing and use.
What is the purpose of a clinical trial?
To assess the safety and efficacy of a new treatment or device.
Which docum...
RAC 40 QUIZ 5 Review | Latest Update |
2024/2025 | Rated A+
What is the main objective of a regulatory submission?
✔✔To obtain approval for a product's marketing and use.
What is the purpose of a clinical trial?
✔✔To assess the safety and efficacy of a new treatment or device.
Which document is essential for the approval of a new drug in the U.S.?
✔✔New Drug Application (NDA).
What does the term "orphan drug" refer to?
✔✔A drug developed to treat a rare disease or condition.
What is post-market surveillance?
✔✔Monitoring the safety and effectiveness of a product after it is on the market.
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, What is the role of the Institutional Review Board (IRB)?
✔✔To ensure ethical standards in clinical research involving human subjects.
What is the primary purpose of Good Manufacturing Practices (GMP)?
✔✔To ensure that products are consistently produced and controlled according to quality
standards.
What does the acronym "FDA" stand for?
✔✔Food and Drug Administration.
What is the significance of a Risk Management Plan?
✔✔To identify and mitigate potential risks associated with a product's use.
What must a company demonstrate to receive a 510(k) clearance?
✔✔That the device is substantially equivalent to a legally marketed device.
What type of information is included in a product label?
✔✔Indications, dosage, administration, and safety information.
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