Accelerated Approval Pathway for Drugs Quiz

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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?

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?

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?

Extensive long-term clinical trials proving efficacy Signup and view all the answers

What is the primary focus of drugs approved via the accelerated approval pathway?

Surrogate markers indicative of a clinical benefit Signup and view all the answers

What is a requirement for pharmacies to dispense Spravato?

Certification in REMS Signup and view all the answers

Why do patients receiving Spravato need to be observed for at least two hours after administration?

To ensure resolution of dissociative effects and sedation Signup and view all the answers

What is one of the potential serious outcomes associated with Spravato that patients need education about?

Sedation and dissociation Signup and view all the answers

Why should healthcare settings treating patients with Spravato be certified in the REMS?

To provide a safe treatment environment Signup and view all the answers

What percentage of patients experience an increase in blood pressure after receiving Spravato?

10% Signup and view all the answers

Accelerated Approval Pathway for Drugs Quiz

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Questions and Answers

What type of diseases are drugs approved for using the accelerated approval pathway?

What can the accelerated approval pathway be based on?

Why are studies to confirm clinical benefit required after accelerated approval?

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 a requirement for pharmacies to dispense Spravato?

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?

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?

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