Category Archives: FDA

The effects of the New FDA Rule for medical device investigations conducted outside the United States

  On February 21, 2019 the new US FDA rule on medical device clinical investigations conducted outside the United States (OUS) became effective. In this post, we would like to discuss the difference between the old and the new regulation and … Continue reading

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The ongoing search for the better early-stage clinical trial location: a case study on Australia and Georgia

International biotech and medtech companies are constantly searching for optimal locations for their early stage and proof-of-concept clinical trials. An example of a location that has become increasingly popular is Australia. This is in large part due to the great … Continue reading

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FDA inspections produce solid evidence of high quality clinical trial data originating in Central and Eastern Europe

Clinical Accelerator is a clinical CRO with a special focus on Central and Eastern Europe currently operating in 11 countries of that region: Bulgaria, Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, Russian Federation, and the Ukraine (listed alphabetically). The … Continue reading

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Find FDA Documents by Name, Text and Other Keywords

OpenTrialsFDA works on making clinical trial data from the FDA (the US Food and Drug Administration) more easily accessible and searchable. Until now, this information has been hidden in the user-unfriendly Drug Approval Packages that the FDA publishes via its … Continue reading

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New draft guidance has just been issued by the US Food and Drug Administration (FDA), which aims to make it easier for medical device companies to rely on data obtained from clinical studies conducted outside the United States (conveniently termed … Continue reading

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