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Easier Access to Experimental Drugs for Serious Illnesses

New rules aim to facilitate access to experimental drugs for individuals with serious or life-threatening diseases for which no other effective therapies exist. These changes could accelerate the availability of innovative treatments, offering hope to patients in difficult situations.
Key points
Experimental drugs designated as breakthrough therapies or authorized for expanded access will be more quickly available to patients.
The facilitations apply to substances actively under investigation with the potential to treat serious diseases where other therapeutic options are lacking.
If a drug no longer meets the criteria or is approved, its status can be changed, ensuring control over its distribution.
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Additional Information
Print number: 118_HR_1393
Sponsor: Rep. Dean, Madeleine [D-PA-4]
Process start date: 2023-03-07