Dec 7, 2022
FDA
The new article highlights the key points related to the determination of a study and reporting status. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance...
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Dec 7, 2022
FDA
The new article highlights the key points related to study population and planning, selection of study participants (subjects), and specimen collection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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Dec 7, 2022
FDA
The new article addresses the aspects related to the evaluation of post-approval study reports. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
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Dec 2, 2022
FDA
The new article addresses the aspects related to the design considerations for diagnostic clinical performance studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Nov 17, 2022
FDA
The article provides an overview of the regulatory provisions related to the definition of a medical device as set forth by the existing legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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