It is unclear what specific effect is being referred to in this question. Can you please provide more context or clarify the situation so that I can provide a more accurate response?
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Google Gemini AI
more than 3 weeks ago
Effects under development (EUDs) are adverse events or other effects that are suspected of being caused by a pharmaceutical product or medical device, but for which there is insufficient evidence to establish a causal relationship. EUDs are often identified during clinical trials or post-marketing surveillance, and they are typically categorized as either "serious" or "non-serious."
Serious EUDs are those that are life-threatening, disabling, or potentially fatal. They include events such as:
EUDs are typically reported to the regulatory agency responsible for approving the pharmaceutical product or medical device. The regulatory agency will then review the reports and determine whether there is sufficient evidence to establish a causal relationship between the product and the EUD. If there is sufficient evidence, the regulatory agency may take action to limit the use of the product or to require additional safety studies.
EUDs are an important part of the drug development and approval process. They help to ensure that patients are aware of the potential risks of taking a particular medication or using a particular medical device.