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.
Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.
D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
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
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
A. Pre-clinical studies
B. Phase I clinical trials
C. Phase I and II clinical trials
D. Phase III clinical trials
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?
A. Certificate of GMP
B. Certificate of Free Sale
C. Certificate of Pharmaceutical Product
D. Certificate of Analysis for the finished product
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?
A. Doha Declaration in the TRIPS Agreement
B. The stability of the drug in all zone conditions
C. The time frame in which the patent will expire
D. International import and export regulations
A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?
A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
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
A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
A. No action is needed in this situation.
B. Prepare regulatory submissions that detail the medical device's change in materials.
C. Review the content of change and supporting data for the equivalency with the current material.
D. Write a memo to file since the change does not impact product safety and effectiveness.
The requirements for document control are located in which of the following documents?
A. ICH guidelines
B. IEC 60601
C. ISO 13485
D. WHO guidelines
