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...
FDA
The new article highlights the key points to be considered for the placebo effect in the context of clinical investigations and also outlines the measures to be taken to mitigate this effect and its impact on the study results and data collected in the course of a...
FDA
The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points addressed in the guidance. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article highlights the key points related to the controls in comparative clinical outcome studies. 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...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the ethical considerations for clinical investigations with children involved. By virtue of the...
FDA
The new article provides additional information regarding the intervention assignment (randomization) for clinical outcome studies and blinding (masking). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
