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Question 29/36
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
Correct Answer: B
- Question List (36q)
- Question 1: One month prior to the anticipated approval date for your pr...
- Question 2: Under which of the following circumstances would a regulator...
- Question 3: According to the GHTF, which of the following is NOT an exem...
- Question 4: An inspection of a manufacturing site determines that a numb...
- Question 5: Company X is planning to acquire the rights for a product ma...
- Question 6: A clinical study of a drug is completed to support a marketi...
- Question 7: Which of the following is the MOST desirable timing and appr...
- Question 8: Company X encounters challenges in the global life cycle man...
- Question 9: After submission to the regulatory authority, a substantial ...
- Question 10: In which section of the ICH Common Technical Document will t...
- Question 11: According to WHO, what are the temperature and humidity cond...
- Question 12: The requirements for document control are located in which o...
- Question 13: A superiority advertising claim for a product versus its com...
- Question 14: Which of the following double-blind clinical trial designs w...
- Question 15: A process is ultimately validated to ensure which of the fol...
- Question 16: You discover that your company's top selling product in the ...
- Question 17: A regulatory affairs professional has submitted a package fo...
- Question 18: A drug product presents degradation during the manufacturing...
- Question 19: Which analysis method is MOST appropriate to prioritize risk...
- Question 20: The manufacturer of an API was changed from Company X to Com...
- Question 21: A company receives multiple complaints regarding the text in...
- Question 22: In addition to protection, what parameters MUST be considere...
- Question 23: During routine surveillance, a regulatory authority sent a c...
- Question 24: According to the GHTF IVD guidance, which of the following i...
- Question 25: A company is developing a device-drug combination product. W...
- Question 26: Which of the following BEST describes the purpose of the ICH...
- Question 27: A manufacturer is involved in a recall event process for a p...
- Question 28: After numerous failed attempts to decrease an identified ris...
- Question 29: In the process of obtaining a product approval, a regulatory...
- Question 30: A company is developing a new product for the global market....
- Question 31: In order to develop a global drug product, what is the MOST ...
- Question 32: Which of the following criteria is MOST appropriate to defin...
- Question 33: During new drug development, a new impurity in the drug subs...
- Question 34: A company establishes a new medical device indication for it...
- Question 35: The regulatory authority in Country X issued a request for a...
- Question 36: A company is developing a new medical device using innovativ...
