RAC-US 문제 26
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
RAC-US 문제 27
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?
RAC-US 문제 28
In which section of the ICH Common Technical Document will the overview of clinical data appear?
RAC-US 문제 29
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
What should be done. What action should the company take FIRST?
RAC-US 문제 30
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?