compassionate use
Desperate patient exception
Compassionate use is the provision of experimental drugs or treatments to patients outside clinical trials, typically when they have serious conditions and no other options exist.
Regulatory agencies may grant compassionate use access before a treatment receives full approval: The FDA authorized compassionate use of the experimental therapy for terminally ill patients.
Incurable, deadly medical condition
- life-threateningRisking death
- experimental treatmentUnproven medical procedure being tested
- off-labelOutside approved indications
- palliativeOffering relief, not remedy
drug development · clinical trial · therapeutic · intervention · disease progression · end-stage · refractory · unmet need
Moral philosophy for medicine
- informed consentPermission given with understanding
- beneficenceActive desire to help
- autonomyIndependent decision-making capacity
- justiceFair treatment under law
equity · allocation · dilemma · morality · risk-benefit · patient rights · advocacy · access
Sudden important advance
- survivalRemaining alive against odds
- quality of lifeGeneral life satisfaction
- remissionTemporary disease absence
- cureTreatment that heals
improvement · progress · miracle · relief · optimism · extension · innovation · benefit
Conditional authorization in advance
- FDAU.S. health regulator
- eligibilityState of meeting criteria
- applicationFormal request document
- authorizationFormal permission granted
fast-track · expedited · oversight · policy · guidelines · protocol · exemption · waiver
terminal illness
Incurable, deadly medical condition
- life-threateningRisking death
- experimental treatmentUnproven medical procedure being tested
- off-labelOutside approved indications
palliative · drug development · clinical trial · therapeutic · intervention · disease progression · end-stage · refractory · unmet need · rare disease
bioethics
Moral philosophy for medicine
- informed consentPermission given with understanding
- beneficenceActive desire to help
- autonomyIndependent decision-making capacity
justice · equity · allocation · dilemma · morality · risk-benefit · patient rights · advocacy · access · fairness
breakthrough
Sudden important advance
- survivalRemaining alive against odds
- quality of lifeGeneral life satisfaction
- remissionTemporary disease absence
cure · improvement · progress · miracle · relief · optimism · extension · innovation · benefit · lifesaving
pre-approval
Conditional authorization in advance
- FDAU.S. health regulator
- eligibilityState of meeting criteria
- applicationFormal request document
authorization · fast-track · expedited · oversight · policy · guidelines · protocol · exemption · waiver · petition
critical
Expressing disapproval or importance
- emergencySerious sudden danger
- life-savingPreventing fatal outcomes
- immediateHappening without delay
terminal · crisis · severe · acute · dire · pressing · urgent · time-sensitive · desperate · rescue
compassion, compassionately, compass, compassing, compassed, passion, passionate, passionately, passions