Pediatric Oncology: Summary of Guidances and Meetings

Guidances

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment

Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Study Plans

Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients 

Meetings

15 Sep: Pediatric Advisory Committee

Will discuss pediatric-focused safety reviews for medications related to acute dystonia associated with  ADHD, acute hyperkinetic movement disorder associated with combined use of ADHD stimulants and  antipsychotics

22-23 Oct: Pediatric Dose Selection Public Workshop ($50)

Will discuss current methods and future approaches, and how to address gaps in pediatric dose selection  that occur because of an inability to perform certain studies in pediatric patients