A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product. To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
A. Label the product for use in appropriate populations.
B. Educate patients and healthcare providers on how to use the product
C. Delay product launch until required studies are completed.
D. Promote off-label use to a carefully selected patient population.
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally. Which of the following is the most appropriate action to take FIRST?
A. Withdraw the affected product from the markets.
B. Send a "Dear Dr." letter to customers.
C. Notify the global regulatory authorities.
D. Assess the potential safety risk.
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
According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
A. 3
B. 5
C. 10
D. 15
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
A. Contact the trade association for advice.
B. Communicate with the relevant internal departments.
C. Prepare documents for the files.
D. Request a permanent waiver from the new regulation.
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
A. Subject is hospitalized due to complications of the product administration.
B. Subject is hospitalized for the purpose of product administration.
C. Subject's hospitalization is due to an unscheduled hip operation.
D. Subject's hospitalization is prolonged during the clinical trial.
A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?
A. Labeling
B. Regulatory application summary
C. Risk management process
D. Safety-related reporting
Which of the following is NOT required to be included in a marketing application?
A. Final printed label
B. Quality, safety, and efficacy Information
C. Administrative forms
D. Evidence of fee payment
A clinical study of a drug is completed to support a marketing approval application. According to ICH,how long should a sponsor retain the clinical study essential documents?
A. For at least two years after the last approval of an application in an ICH region
B. Fora minimum of 10 years after completion of the clinical study
C. Three years after the last clinical study site was supplied with investigational drugs
D. Until the product has been discontinued from marketing in all ICH regions
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Randomization scheme and codes
B. Protocol and protocol amendments
C. ListoflECsorlRBs
D. Detailed CVofall investigators
