expedited
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 […]
Reporting Timeline Asymmetry in Pharmacovigilance
When we think about expedited reporting of adverse events, the number 15 usually comes to mind first. It is the industry default: serious reports generally go out within 15 calendar days, and non-serious ones within 90. But that word “generally” hides a lot of complexity. While the 15-day rule is the golden standard in major […]