Rolling Review – The New Normal?
In general, the overall process of product identification to authorization, may take at least 5-10 years. However, in case of pandemics, public health emergencies, or certain other cases, the overall timeline may need to get shortened. One such action, that supports this, is the rolling review. A rolling review is a regulatory tool, that the […]
Tags: emergency , expedited , pharmacovigilance , public health , review , rolling , safety , vaccine ,
The ‘Four Facets’ of Unlicensed Medicines, and the Pharmacovigilance Impact
The COVID-19 situation made it possible for regulatory agencies globally to explore all the four facets of unlicensed medicines, namely: 1. Emergency Use Authorization 2. Compassionate Use 3. Named Patient Basis 4. Expanded Access Program The first and foremost thing to understand is that the medicine in question can fall into any of the following […]
Tags: compassionate , emergency , expanded access , named patient , pharmacovigilance ,