Newsletter - August 25, 2016
Clinical Trials in Pets: Less Expensive and More Promising
Our pets share not just our homes and hearts but also our life style and diseases. In many ways our dogs and cats are much closer representatives of humans than any test animal. So, can drugs be tested in a clinical trial in our pets to find out the ones that hold more promise in humans? NIH and the National Academy of Science think so, and for good reasons. Read More..
FDA’s Updated GLP Rules Will Disallow Most Academic Non-Clinical Studies from Regulatory Applications
This week FDA announced a major modernization of the GLP rules primarily aimed at adding detailed quality system requirements such as requiring that GLP facilities maintain detailed SOPs on the responsibilities of management, period assessment of the quality system, and electronic documentation. Per the new rules the management of a given facility will be held responsible for any deficiencies identified in the quality systems. Read More..
Clinical Trials in Pets: Less Expensive and More Promising
Our pets share not just our homes and hearts but also our life style and diseases. In many ways our dogs and cats are much closer representatives of humans than any test animal. So, can drugs be tested in a clinical trial in our pets to find out the ones that hold more promise in humans? NIH and the National Academy of Science think so, and for good reasons. Read More..
FDA’s Updated GLP Rules Will Disallow Most Academic Non-Clinical Studies from Regulatory Applications
This week FDA announced a major modernization of the GLP rules primarily aimed at adding detailed quality system requirements such as requiring that GLP facilities maintain detailed SOPs on the responsibilities of management, period assessment of the quality system, and electronic documentation. Per the new rules the management of a given facility will be held responsible for any deficiencies identified in the quality systems. Read More..
