FDA - Expanded Access Flashcards
What is the primary purpose of the FDA’s Expanded Access provision?
To allow patients with serious or life-threatening conditions to access investigational drugs or devices.
True or False: Expanded Access is available for any type of medical condition.
False
What are the three main categories of Expanded Access?
Individual patient, Intermediate-size patient population, and Large patient population.
Fill in the blank: Expanded Access is also known as _______.
compassionate use
What must a patient provide to be eligible for Expanded Access?
Informed consent
What does the FDA require from manufacturers when granting Expanded Access?
The manufacturer must provide the investigational drug or device.
True or False: Expanded Access can be granted for drugs that are not under investigation.
False
What is the role of a physician in the Expanded Access process?
The physician must determine that the patient has no comparable or satisfactory alternative treatment options.
Multiple Choice: What type of patient population does the Intermediate-size patient population category refer to?
A group of patients that is larger than an individual but smaller than a large population.
What is required for a drug to qualify for Expanded Access?
The drug must have completed Phase 1 of clinical trials.
True or False: Patients must pay for drugs received through Expanded Access.
True
Fill in the blank: The FDA requires that Expanded Access requests be submitted through a _______.
form
What is the FDA’s stance on the safety and efficacy of drugs accessed through Expanded Access?
The FDA does not guarantee the safety and efficacy of these drugs.
What must be reported to the FDA after a patient receives a drug through Expanded Access?
Adverse events and outcomes.
What does IND stand for in the context of Expanded Access?
Investigational New Drug
True or False: Expanded Access can be used for drugs that are already FDA-approved.
False
What is the first step for a physician seeking Expanded Access for a patient?
Submit a request to the FDA.
Multiple Choice: Which of the following is NOT a requirement for Expanded Access?
The drug must be widely available.
What is the maximum duration for which an Expanded Access protocol can be approved?
It varies, but it is typically for the duration of the clinical trial.
Fill in the blank: Expanded Access is meant for patients with _______ conditions.
serious or life-threatening
What is the significance of the term ‘compassionate use’ in relation to Expanded Access?
It emphasizes the ethical aspect of providing potentially life-saving treatments.
True or False: The FDA can deny an Expanded Access request.
True
What is the role of Institutional Review Boards (IRBs) in Expanded Access?
IRBs must review and approve the Expanded Access protocol.
What is a key difference between Expanded Access and clinical trials?
Expanded Access is for patients who do not qualify for clinical trials.
Multiple Choice: Which patient population can utilize the Individual Patient Expanded Access pathway?
A single patient with a serious condition.
What information must be included in a request for Expanded Access?
Patient’s medical history, treatment options tried, and the rationale for the request.
