What are Compassionate Use Programs?

‍Compassionate use programs, also known as expanded access, provide pathways for seriously ill patients to access experimental treatments not yet approved by the FDA. These programs are designed for patients who have exhausted all other treatment options and cannot participate in clinical trials.

Why are compassionate use programs important?

• Last resort options: Provides hope when standard treatments fail.
• Early access: Allows use of promising therapies before approval.
• Life-saving potential: May extend or improve quality of life.

Eligibility requirements

• Serious or life-threatening condition.
• No comparable approved treatments available.
• Unable to participate in clinical trials.
• Potential benefits outweigh risks.

How Solace can help

‍A Solace advocate can help navigate the complex compassionate use application process, coordinate with pharmaceutical companies and FDA, and work with your healthcare team to gather necessary documentation. They can also help explore all available options and manage expectations.