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HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION (HCTERS) Publ... Page 1 of 2FDA Home Page | Contact eHCTERS Technical Support HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION Public Query Establishment
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Obtain the necessary supplies including a petri dish, pipette, cell culture medium, and human cells/tissue samples.
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Carefully transfer the human cells or tissue samples into the petri dish using a pipette.
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Who needs human cell and tissue?

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Researchers in the fields of cell biology, genetics, and regenerative medicine who study human cells and tissues for various purposes such as understanding disease mechanisms, developing new therapies, and testing drug efficacy.
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Pharmaceutical companies that conduct research and development of new drugs and treatments using human cell and tissue models.
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Human cell and tissue refer to biological materials that come from human donors. These materials can include cells, tissues, and organs that may be used for research, transplantation, or therapeutic purposes.
Entities that process, store, or distribute human cells and tissues, such as tissue banks, medical facilities, and research institutions, are required to file human cell and tissue.
To fill out human cell and tissue filings, entities must collect and report relevant information about the cells or tissues, including donor details, processing methods, and intended use. They should follow specific guidelines provided by regulatory authorities.
The purpose of human cell and tissue is to provide essential materials for medical treatments, research studies, and advances in regenerative medicine, enhancing the understanding and treatment of various diseases.
Information that must be reported includes donor identification, type of tissue or cells, processing methods, storage conditions, and timestamps of collection and usage.
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