All posts tagged: FDA

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 […]

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CAC2 Webinar–What is a Pediatric Study Plan?

Our May CAC2 All-Member webinar focused on how pediatric cancer study plans are developed.  CAC2 Member Kelli Wright (CureSearch) introduced Dr. Brenda Weigel from University of Minnesota’s Masonic Cancer Center and Dr. Samuel Blackman of Day One Biopharmaceuticals as they addressed: What is a Pediatric Study Plan (PSP)? How is it created and by who? How does FDARA/RACE for Children impact PSP development? Where in the process are the opportunities to create better PSPs? Currently, regulatory agencies require that a pharmaceutical or biotechnology company submit a Pediatric Study Plan (PSP) to confirm the suitability of drug usage in the pediatric [...] Read more