One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?
A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
B. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."
C. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
D. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
A. Quality improvement
B. Quality assurance
C. Clinical affairs
D. Regulatory agency
In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
A. Potential clinical sites for the Phase III clinical trial
B. Regulatory requirements for labeling and packaging
C. Capacity of the manufacturing facilities to fully produce the new product
D. Previous actions taken by regulatory authorities on similar products
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?
A. Allow doctors to use the product for the off-label indication.
B. Communicate with the sales department to stop using the promotional materials.
C. Contact the marketing department to recall the product.
D. Request that doctors stop using the product for the off-label indication.
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?
A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
C. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
A. Conduct a Phase III study for a new unrelated indication of the drug.
B. Develop a generic version of the drug.
C. Develop a better brand-name drug in the same class.
D. Explore litigation strategy for patent infringements on the drug.
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?
A. Expiration date
B. Relevance to regulations
C. Revision history
D. Scope and level of detail
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
A. Systematic procedure to review published scientific journals
B. Systematic procedure to review experiences with the products in use
C. Vigilance procedure to ensure the full traceability of the products
D. Vigilance procedure to notify the regulatory authorities about serious incidents
According to ISO 14971,what is the FIRST step when developing a risk management plan for a medical device?
A. Risk estimation
B. Risk analysis
C. Risk control
D. Risk management
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
A. Deleting an ingredient of the drug product
B. Deleting a drug substance
C. Introducing a new analytical method
D. Strengthening a precaution to the product labeling
Nowadays, the certification exams become more and more important and required by more and more enterprises when applying for a job. But how to prepare for the exam effectively? How to prepare for the exam in a short time with less efforts? How to get a ideal result and how to find the most reliable resources? Here on Vcedump.com, you will find all the answers. Vcedump.com provide not only RAPS exam questions, answers and explanations but also complete assistance on your exam preparation and certification application. If you are confused on your RAC-GS exam preparations and RAPS certification application, do not hesitate to visit our Vcedump.com to find your solutions here.