Animal Testing, Clinical Development and Protein Expression

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Animal Testing

Clinical Development

Protein Expression

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

Therapies

Therapies FDA Production Disease

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

Drug Development

Drug Development Clinical Supply Production Protein Expression

Drug Discovery Digest

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Rapid delivery of toxicological material

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