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