Podcast
Questions and Answers
What type of diseases are drugs approved for using the accelerated approval pathway?
What type of diseases are drugs approved for using the accelerated approval pathway?
- Common diseases with many treatment options
- Mild diseases with no available treatments
- Serious diseases with few good treatments (correct)
- Chronic diseases with experimental treatments
What can the accelerated approval pathway be based on?
What can the accelerated approval pathway be based on?
- Reduction in beta-amyloid plaques (correct)
- Long-term clinical benefits
- Cost-effectiveness studies
- Patient satisfaction surveys
Why are studies to confirm clinical benefit required after accelerated approval?
Why are studies to confirm clinical benefit required after accelerated approval?
- To hinder patient access to new treatments
- As a formality with no real effect
- To increase the cost of drugs
- To ensure the drugs are effective in real-world scenarios (correct)
Which of the following is NOT a reason for drugs to be approved through the accelerated approval pathway?
Which of the following is NOT a reason for drugs to be approved through the accelerated approval pathway?
What is the primary focus of drugs approved via the accelerated approval pathway?
What is the primary focus of drugs approved via the accelerated approval pathway?
What is a requirement for pharmacies to dispense Spravato?
What is a requirement for pharmacies to dispense Spravato?
Why do patients receiving Spravato need to be observed for at least two hours after administration?
Why do patients receiving Spravato need to be observed for at least two hours after administration?
What is one of the potential serious outcomes associated with Spravato that patients need education about?
What is one of the potential serious outcomes associated with Spravato that patients need education about?
Why should healthcare settings treating patients with Spravato be certified in the REMS?
Why should healthcare settings treating patients with Spravato be certified in the REMS?
What percentage of patients experience an increase in blood pressure after receiving Spravato?
What percentage of patients experience an increase in blood pressure after receiving Spravato?
