Patient Experience Data Mandatory in New Drug Approval Risk Assessment
This Act aims to strengthen the role of patient experience data in the FDA's framework for approving new drugs. It mandates that the FDA must formally consider patient experience data when assessing the risks and benefits of new therapies. This change could lead to faster approval of drugs that significantly improve patients' quality of life, ensuring that the patient's perspective is central to regulatory decisions.
Key points
Requires the FDA to formally consider patient experience data as part of the risk-benefit assessment framework for new drug approvals.
Increases the influence of the patient's perspective on drug approval decisions, potentially speeding up access to beneficial treatments.
Medical product sponsors or other parties can submit patient experience data, which must be documented in the drug approval process.
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