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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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Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical…

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Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement is a legal written contract which ensures that all safety…

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