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Phase IV Surveillance

Meaning

Phase IV Surveillance, also known as post-marketing surveillance, is the crucial, ongoing stage of drug safety and efficacy monitoring that occurs after a therapeutic agent has received regulatory approval and is widely available for clinical use. This phase is designed to monitor the drug’s long-term effects in a large, diverse patient population, enabling the detection of rare or delayed adverse drug reactions and drug-drug interactions not apparent in smaller pre-approval trials. It represents the continuous clinical commitment to patient safety and risk management.