Remdesivir, the only drug cleared to treat Covid-19, sped the recovery time of patients with the disease, but its benefit appeared much more limited in patients who needed mechanical ventilation as part of their treatment. Although the antiviral agent remdesivir has been shown to shorten recovery time in patients with …
Signal Management Definition: A set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or …
What is Signal? A signal is essentially a hypothesis of a risk with a medicine with data and arguments that support it, derived from data from one or more of many possible sources. The evidence in a signal is not conclusive (is, in the technical sense, uncertain), and is only …