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FDA approval requires an application with evidence on quality, safety, and effectiveness for a specific medical use
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Not for human or veterinary use Not intended for medical administration Not intended for food, cosmetic or household applications Not intended to diagnose, treat, cure or prevent any disease To be handled only by suitably qualified laboratory personnel By purchasing this product, the buyer confirms that it will be used solely within a lawful laboratory research environment and in accordance with all applicable laws, regulations and laboratory procedures
However, data on use beyond 6 months in humans remains limited
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