Saudi FDA allows more time to address deficiencies in drug submissions
This article was originally published in SRA
The Saudi Food and Drug Authority has issued a revised guideline that provides pharmaceutical companies with more time to respond to deficiencies in their submissions concerning new marketing authorisations, renewals and variations to existing products1,2.
You may also be interested in...
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.
Existing importers and manufacturers of certain medical devices can continue marketing their products for six months or until the Indian medtech regulator makes a final decision on their pending licensing applications.
Differences between how Australia and the EU define “central circulatory system” has resulted in different risk classification levels being assigned to some devices in the two jurisdictions.