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In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to lo...

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - [A] Agreement meeting [Q]Which meeting hel...

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C...

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of s...

Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOOD...