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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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Neuroblastoma Drug Development: Potential Surrogate Endpoint Gets US FDA Panel Backing

Advisory committee supports further research on end-of-induction response as an early interim clinical endpoint for drugs in treatment of high-risk neuroblastoma. FDA has approved two drugs for this rare disease in children, who have a 40-50% chance of long-term survival.

Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs

Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.

Moderna COVID Vaccine EUA For Kids Younger Than Six Will Be Big Test For FDA Efficacy Threshold

Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’

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