The article describes the approach to be applied with respect to viral mutations and their potential impact on the performance of tests intended to identify the virus. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority...
The new article highlights the aspects related to the scope of information and documentation the authority expects to be included in requests from interested parties. Table Of Contents: The Medical Device Authority (MDA), a Malaysian regulating authority, has...
The new article provides an overview of the revised guidance document and outlines the key points associated thereto. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The new article addresses the aspects related to different grounds for delays occurring before and during an inspection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The article provides an overview of the factors resulting in delaying or refusing an inspection. 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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...