Regulating Unapproved Drugs in the US: the Role of DESI and FDA Approval Pathways

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• Regulatory pathways significantly influence the access and safety of unapproved drugs, ensuring public health.
• The FDA approval process is crucial for assessing the efficacy and safety of medications before they reach patients.
• DESI plays a vital role by evaluating older drugs that may not have undergone standard approval processes.
• Understanding these regulatory frameworks is essential for improving drug availability and public health standards.