Australia and Oceania
The new article highlights certain specific aspects related to 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 guidance document...
Australia and Oceania
The new article describes in detail the approach to be followed with respect to the aspects related to the preparation and submission of the reports on post-approval studies, including the general information about the types of reports and submission timelines. Table...
Australia and Oceania
The new article highlights the aspects related to study protocols for post-approval 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 guidance document...
Australia and Oceania
The new article describes in detail the aspects related to the content of deficiency letters, their review, as well as the way the authority expects the industry to respond to such letters. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
Australia and Oceania
The article provides an overview of the regulatory requirements related to handling post-approval 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...
Australia and Oceania
The new article highlights the most important aspects related to the application of the least burdensome approach for deficiencies arising from the issues identified by the authority when reviewing the application for marketing approval. Table of Contents The Food...
