FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Agency IQ

JULY 21, 2023

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. But unlike ORR, PFS is considered by FDA to be a more appropriate measure of stable disease and is thought to be correlated to overall survival.

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FDA Clinical Trials DNA Treatment 40

Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. after ischemic heart disease and stroke. See AgencyIQs analysis of a workshop on novel methodology qualification.] were from cancer.

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