New Pediatric Cancer Drugs, Research Support, and FDA Transparency
This act aims to accelerate research and availability of pediatric cancer drugs, especially molecularly targeted ones. It modifies drug approval processes, increases pharmaceutical companies' accountability for pediatric studies, and extends incentives for rare pediatric disease treatments. Additionally, it establishes an FDA office in Abraham Accords countries and introduces registration fees for the organ transplant network.
Key points
Facilitates research into new pediatric cancer drugs, including molecularly targeted therapies, potentially speeding up access to innovative treatments.
Increases accountability for pharmaceutical companies to conduct pediatric drug studies, with penalties for lack of due diligence, ensuring drug safety and efficacy for children.
Extends the priority review voucher program for rare pediatric disease drug development until 2029, incentivizing therapies for young patients.
Modifies market exclusivity rules for orphan drugs, potentially impacting the availability of more affordable alternatives.
Establishes an Abraham Accords Office within the FDA to foster regulatory cooperation and facilitate access to the U.S. market for medical products from these countries.
Introduces registration fees for Organ Procurement and Transplantation Network members to support its operations and enhance financial transparency.
Expired
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