To support ongoing drug safety, biopharmaceutical manufacturers must report adverse drug events (ADEs) to regulatory agencies, such as the US Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the EU. Adverse drug reactions or events are medical problems that occur during treatment with a drug or therapy. Of note, ADEs do not necessarily have a casual relationship with the treatment. But in aggregate, the proactive reporting of adverse events is a key part of the signal detection system used to ensure drug safety.
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