China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its Support Anti-tumor drugs R&D for Kids (SPARK) project within one month. This initiative marks a significant step forward in promoting the development of pediatric antitumor drugs.
Project Background
The SPARK project is a pilot effort in the pediatric medicine field based on the “patient-centered action for rare diseases encouragement (CARE)” program. It aims to facilitate communication between applicants and the CDE, enabling early and efficient dialogue in the development of pediatric antitumor drugs.
Implementation Framework
Applicants are encouraged to submit the “Implementation Framework for Research and Development of Children’s Antitumor Drugs” form as soon as possible after filing. This will allow them to obtain guidance on various aspects of drug development, including R & D strategy, study design, experimental drug dosage, application of advanced tools, and development of dosage forms suitable for pediatric populations.-Fineline Info & Tech
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