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The SynchroMed II application provides visual tools, such as flex dosing graphics, and guided workflows, with the goal of simplifying treatment management. Read More
New draft regulation spells out qualification requirements for medical reps, including a two-year junior college degree or higher with a major in life sciences. Read More
The FDA worked with Baxter to help restore production as the previously existing shortages of IV saline and amino acids for injections had been exacerbated when Hurricane Maria struck. Read More
The firm’s CAPA procedures at the time of the FDA site inspection did not include processes for analyzing quality data that could help to identify any issue other than nonconforming product. Read More