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FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

Molecular factors Molecular markers, such as protein expression and signalling pathway activation, also guide therapy choices. For example, PD-L1 expression predicts the response to immune checkpoint inhibitors. Adaptive Clinical Trial Design in Oncology: An Overview. Food and Drug Administration. FDA.gov biotx.ai

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured. Tobolowsky & Charles G. Raver & James E.