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NEW QUESTION 49
Why is it necessary to run supplemental safety pharmacology studies?

A. To provide adverse reaction reports and the results of the statistical data to the regulatory authorityB. To substitute the utilization of GLPC. To comply with regulatory authority requirements related to clinical studiesD. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

Answer: D

 

NEW QUESTION 50
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Product release and validationB. Concept development and validationC. Early technical design and product releaseD. Concept development and early technical design

Answer: D

 

NEW QUESTION 51
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A. Relevance to regulationsB. Expiration dateC. Revision historyD. Scope and level of detail

Answer: A

 

NEW QUESTION 52
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

A. Identify countries where special requirements exist during the product development phase.B. Utilize the STED template to complete global requirements.C. Initiate a global submission process after all submission data are finalized.D. Plan regulatory approval update meetings with senior management and stakeholders.

Answer: A

 

NEW QUESTION 53
Which of the following is NOT required to be included in a marketing application?

A. Administrative formsB. Quality, safety, and efficacy InformationC. Evidence of fee paymentD. Final printed label

Answer: C

 

NEW QUESTION 54
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