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Phase IV studies, also known as post-marketing surveillance, evaluate the long-term safety and effectiveness of medicines after regulatory approval. These studies contribute to ongoing benefit–risk assessment in real-world clinical settings.
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Drug recalls are structured regulatory actions taken to address quality, safety, or labeling concerns associated with medicinal products. Clear procedures and defined responsibilities ensure patient protection and supply chain integrity.
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Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain and inflammation management. Appropriate patient selection and risk assessment are essential to minimize gastrointestinal and cardiovascular complications.
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Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issue safety alerts to communicate emerging risks associated with medicinal products. These alerts support timely risk mitigation and informed clinical decision-making.
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