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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Despite challenges in enrolling pediatric patients with rare cancers in trials, KRISTEN WESSEL of the FDA’s Division of Clinical Pharmacology recently argued that it’s not impossible.

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