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Monthly Archives: October 2015

Share on Google+ October 16, 2015

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

Category : FDA, GLP, In-vivo Testing, Medical Device testing, Study Management, Uncategorized

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July 29, 2010. The Big Picture

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