FDA and NCI Draft Pediatric Molecular Target List
Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions.The efforts from FDA, with input from the National Cancer Institute (NCI), are meant to increase the number of written requests for pediatric studies of new drugs developed for adult cancers earlier in the development timeline.
“This list includes 1) molecular targets for which existing evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and 2) those targets for which there is evidence that they are not associated with the growth or progression of pediatric tumors for which requirement for early pediatric evaluation of drugs and biologics which are directed at these targets would be waived,” FDA said.
The agency said the list fulfills the statutory requirements imposed by FDARA and is expected to provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/or biologic products in development for cancer.
Pediatric Molecular Target List without references
Pediatric Molecular Target List with references