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Videos, Slides, Films
Regulatory development for gene and cell-therapies in the United States
- Author / Creator
- Available as
- Online
Details
- Creator
- Carolina Iglesias-Lopez
- Format
- Videos, Slides, Films
- Language
- English
- Publication
-
- London : Henry Stewart Talks, 2023
- Physical Details
-
- 1 videorecording (25 min., 19 sec.) : sound, color
- video file
- Animated audio-visual presentation with synchronized narration.
- Title from title frames.
- Contents: US regulation of cell and gene therapies -- Gene therapies -- Cell-engineering -- Cell therapy -- Advanced therapies medicinal products (ATMP) -- Definition and classification of cell and gene therapies -- Drug regulatory affairs -- Biological drugs -- Drug development -- Clinical development -- Pre-IND meetings -- BLA review -- Special Protocol Assessment (SPA) -- Fast track, breakthrough and RMAT Designation
Subjects
- Cellular therapy -- Law and legislation -- United States.
- Drug development -- Law and legislation -- United States.
- Gene therapy -- Law and legislation -- United States.
- Biological Products.
Medical Subject Heading
- Cell- and Tissue-Based Therapy -- legislation & jurisprudence.
Medical Subject Heading
- Cell Engineering.
Medical Subject Heading
- Drug Development -- legislation & jurisprudence.
Medical Subject Heading
- Genetic Therapy -- legislation & jurisprudence.
Medical Subject Heading
- Legislation, Drug.
Medical Subject Heading
- United States. Food and Drug Administration.