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FDA Getting Tough on Human Tissue Companies

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In follow up to the FDA’s implementation of a Human Tissue Task Force to address the ongoing concerns related to the harvesting of tainted human tissue for cadavers, the government has issued a guidance reminding companies which manufacture human cells, tissues, and cellular and tissue-based products that they must comply with FDA regulations.

The FDA says in a statement that the guidance is intended to ensure companies involved in any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and screening or testing of the cell or tissue donor, are aware of their regulatory responsibilities.

The Food and Drug Administration has heightened its scrutiny after discovering that at least 2 companies had harvested tissue from bodies that were not properly screened exposing recipients of this tissue to increased risk of infectious disease including hepatitis and HIV. We believe this is only the tip of the iceberg.

The message being sent is that this industry needs an overhaul in order to assure patient safety.

Current good tissue practices require manufacturers to recover, process, store, label, package and distribute human cells or tissues in a way that prevents the introduction, transmission, or spread of communicable diseases and prevents contamination during manufacturing.