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Newsletter - November 2, 2017
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Physician’s Perspective on Simplifying Clinical Trials

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Physicians are increasing frustrated with the increasing complexity of clinical trials, in their opinion, and the seeming duplication of work that could be avoided by better use of available technology. A commentary published in MedScape by Dr. John Marshall of the Lombardi Comprehensive Cancer Center... Read More

FDA Follows Through on its Promise to Recognize European GMP Audits 


In early September, FDA and EMA announced that they will start recognizing each other’s GMP audits and starting Nov 1 FDA announced that it has started this with eight European countries. As of 1 Nov 2017, if a manufacturing site passed an audit by regulators from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom; it will likely not need another audit from FDA. Read More

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