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 I...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-12
DOI
https://doi.org/10.58079/13axn
Primary Topic
Geophysical and Geoelectrical Methods
Type
article
Field-Weighted Citation Impact
0.00
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article

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)

Industrias Culturais (Universidade de Coimbra)
Geophysical and Geoelectrical Methods
article

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)

article en

Abstract

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 I...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 51%
Geophysical and Geoelectrical Methods
DOIOpen Access PDFOpenAlex
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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) · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS