FDA - Emergency Use Flashcards
What is the primary purpose of the FDA’s compassionate use regulations?
To provide access to experimental treatments for patients with serious or life-threatening conditions.
True or False: Compassionate use is only available for patients enrolled in clinical trials.
False
What is another term often used interchangeably with ‘compassionate use’?
Expanded access
Fill in the blank: The FDA’s compassionate use regulations fall under ___________ regulations.
Investigational New Drug (IND)
What type of patients are eligible for compassionate use programs?
Patients with serious or life-threatening diseases who have no other treatment options.
Which form must a physician submit to request compassionate use of an investigational drug?
Form 3926
True or False: The FDA must approve each compassionate use request.
True
What is one requirement for a drug to qualify for compassionate use?
The drug must be under investigation in clinical trials.
Multiple Choice: Who can request compassionate use on behalf of a patient?
A) The patient B) A physician C) A family member D) All of the above
What is the role of the Institutional Review Board (IRB) in compassionate use?
To review and approve the compassionate use protocol.
Fill in the blank: Compassionate use is primarily designed for patients who are __________.
Not eligible for clinical trials
True or False: Compassionate use programs can be initiated by pharmaceutical companies.
True
What is the difference between compassionate use and clinical trials?
Compassionate use provides access to unapproved drugs outside of clinical trials, while clinical trials are structured research studies.
What must be demonstrated about the investigational drug for compassionate use to be granted?
That it has potential benefits that outweigh the risks.
Multiple Choice: Which of the following is NOT a requirement for compassionate use?
A) The drug must be commercially available B) The patient must have a serious condition C) No other treatment options should be available D) The drug must be under investigation
What does the FDA’s compassionate use policy aim to balance?
Patient access to investigational therapies and safety considerations.
True or False: Compassionate use requests can be denied by the FDA for any reason.
True
What is a key ethical consideration in compassionate use?
Ensuring informed consent from the patient.
Fill in the blank: The FDA provides ___________ guidance to help navigate compassionate use requests.
Regulatory
What is one potential consequence of compassionate use programs?
They may divert resources from clinical trials.
Multiple Choice: What is the FDA’s stance on the availability of compassionate use?
A) It encourages compassionate use B) It discourages compassionate use C) It is indifferent D) It requires compassionate use
What does the term ‘serious condition’ refer to in the context of compassionate use?
A disease or condition that is life-threatening or significantly impairs daily functioning.
True or False: Compassionate use can apply to both drugs and medical devices.
True
What is a common misconception about compassionate use?
That it guarantees access to any investigational drug.
What is the expected outcome of compassionate use for patients?
To potentially improve their health condition when no alternatives are available.
