FDA CBER Office of Therapeutic (OTP) town Hall: Cell therapy CMC readiness for late-stage INDs (from Catapult’s regulatory round-up for November 2024)
During the September 5th September 2024 CBER OTP Town Hall, subject matter experts answered questions regarding development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs) intended to collect primary evidence of effectiveness to support a marketing application for both cell therapy and tissue-engineered products. Transcript for the FDA CBER OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs is now available here.
Published on the 3rd of december 2024. Read the entire Regulatory Round-up – November 2024 here.
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adelage (12 février 2025). FDA CBER Office of Therapeutic (OTP) town Hall: Cell therapy CMC readiness for late-stage INDs (from Catapult’s regulatory round-up for November 2024). ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/13axn