Category Archives: FDA

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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MEDICAL DEVICE COMPANIES CAN RELY ON SOUND FOREIGN CLINICAL DATA SAY NEW DRAFT FDA GUIDELINES

New draft guidance has just been issued by the US Food and Drug Administration (FDA), which aims to make it easier for medical device companies to rely on data obtained from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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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 the region: Belarus, Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, Russian Federation and Ukraine (listed alphabetically). ┬áThe quality … Continue reading

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