Mandating Pediatric Cancer Research for New Targeted Drugs
This law aims to speed up access to modern cancer treatments for children. It requires pharmaceutical companies developing new targeted cancer drugs (often initially for adults) to also conduct specific pediatric investigations if the drug targets a molecular pathway relevant to childhood cancers. This change increases the amount of clinical data available, potentially leading to faster approval of life-saving therapies for young patients.
Key points
Drug companies must now study new cancer drugs for pediatric use if the drug targets a molecular mechanism relevant to childhood cancer growth.
These required studies can involve testing the new drug in combination with existing standard-of-care treatments or other approved adult cancer drugs.
The goal is to gather crucial data on safety, dosing, and effectiveness using appropriate formulations for children.
Expired
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