Assay Development, Regulations and White Paper

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Assay Development

Regulations

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

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 workshop is also discussed in Cell & Gene here and here.

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

In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.

FDA

FDA Clinical Trials DNA Treatment

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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