Allows patients with life-threatening diseases to access investigational individualized medical treatments.
The Right to Try for Individualized Treatments Act amends the Federal Food, Drug, and Cosmetic Act to allow patients diagnosed with a life-threatening disease or condition or severely debilitating illness to access investigational individualized medical treatments. These treatments are based on a patient's unique genomic profile. Patients must have exhausted all approved treatment options and be unable to participate in a clinical trial. The bill also requires manufacturers to comply with federal assurance laws and regulations and operate within eligible health care facilities.
Included in complete analysis
- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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