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X-ORIGINAL-URL:https://www.cac2.org/
X-WR-CALNAME:CAC2
X-WR-CALDESC:Coalition Against Childhood Cancer
X-WR-TIMEZONE:America/New_York
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TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20260308T030000
RRULE:FREQ=YEARLY;BYMONTH=03;BYDAY=2SU
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TZOFFSETFROM:-0400
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TZNAME:EST
DTSTART:20261101T010000
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CLASS:PUBLIC
UID:MEC-03fcb1b305029b58d302e2ce53be9e0f@cac2.org
DTSTART;TZID=America/New_York:20220511T100000
DTEND;TZID=America/New_York:20220511T153000
DTSTAMP:20250623T142830Z
RRULE:FREQ=DAILY;UNTIL=20220512T193000Z
CREATED:20250623
LAST-MODIFIED:20260506
PRIORITY:5
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TRANSP:OPAQUE
SUMMARY:Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting
DESCRIPTION:On May 11, 2022, the subcommittee will discuss the development of a conceptual framework that will inform the decision-making of the FDA on sponsor plans and requests for waivers of early pediatric investigations of molecularly-targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development, recognizing that the rarity of pediatric cancers may preclude the feasibility of investigations of multiple products. Investigation of more than one product may be appropriate when specific product characteristics predict an improved benefit-risk assessment that warrants clinical investigation.\nOn May 12, 2022, the subcommittee will consider and discuss the potential utility and steps to validation of an intermediate clinical endpoint, response to induction therapy, in the development of new drugs for the first-line treatment of patients with high-risk neuroblastoma. The European Medicines Agency (EMA) has also been invited to present on both days.\n
URL:https://www.cac2.org/cac2c-events/pediatric-oncology-subcommittee-of-the-oncologic-drugs-advisory-committee-meeting/
CATEGORIES:Community Event,Professional Meeting,Virtual Event
LOCATION:Silver Springs, MD 20993
ATTACH;FMTTYPE=image/png:https://www.cac2.org/wp-content/uploads/2025/06/Virtual-Program.png
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