Author name: florent.maestracci

Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry

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https://www.fda.gov/media/77497/download

Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry

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https://www.fda.gov/media/79856/download

BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry

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https://www.fda.gov/media/86387/download

IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA Staff

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https://www.fda.gov/media/89441/download

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors

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https://www.fda.gov/media/73624/download

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry

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https://www.fda.gov/media/73072/download

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration Staff

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https://www.fda.gov/media/109176/download

EMA Eudralex Volume 4 Annex 1 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

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https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf

Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry

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https://www.fda.gov/media/72402/download

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry

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https://www.fda.gov/media/113790/download