38 Questions
What does FDA expect for drug-led combination products?
A HF simulated-use or actual-use validation study
Under what circumstances does FDA expect a HF actual-use validation study?
When it is difficult to simulate the conditions of use
What is expected from Blood Center ABC in its operations?
Manufacture blood and blood products from volunteer blood donors
Who are the intended recipients of the blood products from Blood Center ABC?
Local dialysis clinics and hospitals in other states
What is not an acceptable way to support marketing authorization of drug-led combination products?
Risk-based rationale to waive the HF validation study
Why might a HF actual-use validation study be needed according to FDA expectations?
When simulating conditions of use is difficult
What type of study is not acceptable according to FDA for drug-led combination products?
Risk-based rationale to waive the validation study
What must accompany a drug-led combination product for marketing authorization?
HF simulated-use or actual-use validation study
What type of variation requires notifying the national competent authorities or the European Medicines Agency immediately upon implementation?
Type 1A
In the context of a medicinal product for human use, what regulatory submission route is appropriate when authorizing a new therapeutic indication after years of successful marketing?
TypeII variation
What are the procedures involved in a non-interventional imposed PASS (Post Authorization Safety Study)?
Upon study completion, a final study report with results must be submitted
When implementing a change that requires immediate notification to authorities, which type of variation is triggered as per EMA guidelines?
Type 1Ain
For a medicinal product with existing marketing success seeking new therapeutic indications, what submission route is most suitable?
Type II variation
What is a key requirement for a non-interventional imposed PASS regarding study completion?
Submission of final study report with results
In what scenario is a Type 1Ain variation commonly required?
Immediate implementation changes requiring notification
What distinguishes a Type II variation from other regulatory submission routes in terms of changes it allows?
'Major' changes affecting product characteristics significantly
Which of the following documents provides information about the product and lot?
Product and lot information
What is the purpose of FDA meeting minutes for formal meetings relating to biological products regulated by CBER?
For input on additional issues not addressed at the meeting, a response should be submitted
What should a regulatory professional do if commercial stability batch testing produces out-of-specification results with no identifiable cause?
Investigate further to identify the cause
Which document might provide information about any changes in ownership of the product?
History of product ownership changes
What action should be taken if the original FDA meeting minutes need to be revised?
Submit a formal request for revision to the FDA
If an issue was not addressed at a formal meeting relating to CBER-regulated products, how should it be handled?
A separate response should be submitted to address the issue
In case of out-of-specification results in commercial stability testing, what is crucial for regulatory professionals?
Promptly identifying the cause of deviation
What is the BEST approach when a company is developing a new line of products in an unfamiliar area?
Obtain regulatory documents and history and summarize them
For lot release of biologics, which of the following is MOST appropriate?
Quality verification
When evaluating the impact of a manufacturing process change in cellular therapy products, what outcome indicates comparability between pre-change and post-change products?
Comparable relevant quality attributes
In drug development, what is a key reason for summarizing regulatory documents?
To inform the management team
Why is safety assurance NOT the most appropriate process for lot release of biologics?
Quality verification is more crucial
What could happen if a company relies solely on competitor research when developing new products in an unfamiliar area?
Limited understanding of market needs
How does summarizing regulatory documents benefit the management team during product development?
Provides key information for decision-making
Which of the following is false regarding FDA expedited programs?
RMAT Designation should be requested with the IND submission
If the FDA informs a company that its autologous cellular therapy product will be regulated as an HCT/P, which of the following regulatory requirements will the company need to comply with during manufacturing?
Current Good Tissue Practice (CGTP) regulations
Which of the following statements is true regarding the evidence requirements for FDA expedited programs?
Breakthrough Therapy Designation and RMAT Designation require evidence of substantial improvement over available therapies
Based on the information provided, which of the following regulatory designations would be most appropriate for a drug that shows promising early clinical evidence of substantial improvement over existing therapies?
Breakthrough Therapy Designation
Which of the following statements is true regarding the level of evidence required for Fast Track Designation?
It is lower than the level of evidence required for Breakthrough Therapy Designation
According to the information provided, which of the following regulatory designations should be requested with the IND (Investigational New Drug) submission?
None of the above
Which of the following statements is correct regarding the evidence requirements for RMAT Designation?
RMAT Designation requires the same level of evidence as Breakthrough Therapy Designation
Based on the information provided, which of the following regulatory designations would be most appropriate for a drug that shows promising early clinical evidence of efficacy but does not demonstrate a substantial improvement over existing therapies?
Fast Track Designation
Test your knowledge on FDA expedited programs with this practice question from the Topic RAC (Drugs) Practice Test. Identify the false statement regarding FDA expedited programs and enhance your understanding of Fast Track Designation, Breakthrough Therapy Designation and RMAT Designation.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
