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Glossary

Somatic-Cell Therapy medicinal Products (sCTP)

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These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases.

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F

Food and Drug Administration (FDA or USFDA)

The FDA is a Federal agency within US Department of Health and Human Services, which…

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D

Development international birth date (DIBD)

Date of first approval (or authorization) for conducting an interventional clinical trial in any country…

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