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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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.

Therapies

Therapies Engineering Production FDA

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials

Clinical Trials Trials Treatment Production

Drug Discovery Digest

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

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