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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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CC Community News Digest (week of August 24-30)

Assorted news from the last week: Cancer and its treatment may accelerate the aging process in young patients Research has identified a small molecule compound that may make some medulloblastoma patients respond better to treatment Childhood Cancer virtual Action Day planned for September 9 Chadwick Boseman, who died of cancer Friday at age 43, inspired many in roles as King T'Challa, Jackie Robinson and James Brown, but also used his prominence to lift up children with cancer. CAC2 salutes Members Solving Kids’ Cancer, Momcology, Ty Louis Campbell Foundation, and the Max Cure Foundation who worked collaboratively with Friends of Karen [...] Read more

CC Community News Digest (week of August 17-23)

Assorted news from the last week: CAC2 urges members to support efforts to help children’s hospitals in Beirut in the aftermath of the deadly August 4 explosion.  You can read more about the explosions effect on pediatric cancer patients from the New York Times American Association for Cancer Research will hold virtual Rally for Medical Research Event on September 17 Researchers to study chemo brain in children with ALL Childhood cancer survivors with severe hearing loss:  significantly increased risk for neurocognitive deficits  independent of what type of therapy they receive THON dance marathon goes virtual RACE for Children Act implemented this week

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CC Community News Digest (week of August 10-16)

Assorted news links from the last week: INCB, WHO and UNODC Statement on Access to Internationally Controlled Medicines during COVID-19 Pandemic FDA Issues Complete Response Letter for Pedmark  An important step forward for mitigating the risk of life-long hearing loss caused by cisplatin AML Survivors at risk for psychosocial impairment Another study from the Childhood Cancer Survivor Study Beirut blast disrupts cancer care for children NPR reports on the wide range of damage from the explosion in Beirut More news about DIPG:  Discoveries point to a new potential treatment approach For childhood cancer survivors, exercise intolerance predicts a range of other health [...] Read more

CC Community News Digest (week of August 3-9)

Assorted news links from the last week: Study Offers Insights on Health Problems among AYA Cancer Survivors Medical trial aims to identify those at risk of heart damage following cancer treatment Australian researchers taking a very broad look at the effect of cancer treatment on heart health. Racial Disparities in Pediatric Cancer Treatment: Black Children Less Likely to Receive Proton Radiotherapy, Forbes US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG, a big win for the Creating Hope Act (which needs to be permanently reauthorized by the end of September) Risk-Stratified Therapy Reduces Late Morbidity, Mortality in Pediatric [...] Read more

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