FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
Australia
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
FDA
The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study
BfArM
The new article highlights the aspects related to the timeframes the applicants should follow.
BfArM
The new article outlines specific requirements to be considered depending on the study type or design.
