FDA
The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests, and also the availability of EUA templates. Table of Contents The Food and Drug...
FDA
The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing medical devices on the US market. Table of Contents The Food and Drug Administration (FDA or...
FDA
The present article describes in detail the aspects related to modifications to tests already approved for use in the US, as well as the ones related to the content of notification and reporting. Table of Contents The Food and Drug Administration (FDA or the Agency),...
FDA
The new article describes in detail the means for reducing the burden of traditional clinical studies, and also the use of benefit-risk assessments. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The present article describes in detail the regulatory approach to be applied concerning monkeypox tests intended to be used in the US in the context of the public health emergency. In particular, the article describes the way the FDA will authorize the use of...
FDA
The article provides a brief overview of the existing regulatory requirements for computer software assurance in the context of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
