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Assay Development

Therapies

White Paper

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).

Therapies

Therapies Engineering Production FDA

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). In fact, the FDA estimates that the accelerated approval program is responsible for access to life-saving anti-cancer therapies a median of 3.4 years before they would have been available otherwise.

FDA

FDA Clinical Trials Treatment DNA

Drug Discovery Digest

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

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

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