Asia
The article provides an overview of the regulatory requirements in the sphere of adverse event reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
FDA
The new article highlights the aspects related to the measures intended to improve the accuracy of the study results and address potential bias. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Canada
The new article describes in detail the aspects related to the submission of clinical evidence in the context of applications for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a...
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...
Brazil
The new article describes in detail the aspects related to the products intended to process medical records, as well as the ones based on the use of non-medical hardware platforms (smartphones). Table of Contents The Brazilian regulating authority in the sphere of...
