The FDA will accept a certain level of risk for a new…
““The FDA will accept a certain level of risk for a new treatment that is to be applied to a group of very sick patients who would otherwise die in the near future, but not for a group who have a relatively long life expectancy on the basis of existing therapies.””
About This Quote
This interpretation was drafted with AI assistance. It is one reading of the quote, not the author's own explanation.
Regulatory bodies accept higher risk for life‑threatening patients but not for those with longer expected lives.
In simple terms: FDA permits risk for critically ill, not for those with better prospects.
Assess risk tolerance based on patient prognosis.
Themes
Mood
Type
When to use this quote
- hospital boards
- pharma companies
- insurance decisions
Key Concepts
Questions to Reflect On
- How should risk be weighed for different patient groups?
- What ethical frameworks guide these decisions?
Balancing risk and benefit is complex.