
FDA Draft Guidance on Third Party Review Program: FDA Expectations
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The article highlights the key points related to the regulatory status of boundary products in Australia.
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.