The article provides an overview of the regulatory requirements related to radiological devices and certain aspects associated thereto. Table of Contents The Food and Drugs Administration (FDA or the Agency), the US regulating...
The new article highlights specific aspects of the principles related to the medical devices emitting radiation, as well as the ones intended to be used by laypersons or containing materials of biological origin. Table of Contents The...
The new article provides additional details regarding the regulatory requirements for the importation of investigational products, as well as other aspects. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP),...
The article provides an overview of the regulatory requirements related to tissue containment systems. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
The new article describes in detail certain specific aspects related to post-market surveillance – in particular, the way the authority is going to communicate important safety-related information to stakeholders. Table of...