FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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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. In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out.

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Agency IQ

FEBRUARY 2, 2024

The European Commission also implemented its Mission on Cancer , which aims to further cancer research and innovation through funding in the same areas as the cancer plan. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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