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Post Authorization Safety Study (PASS) Information Acronym / TitleURANIS Data collection in urological centers during treatment with Ra223 dichloride (Fight) within the framework of a nonintervention
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Pharmaceutical companies seeking to ensure the safety and efficacy of their products post-authorization
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A post authorization safety study is a research study conducted after a drug or therapy has been approved for marketing to assess its safety in a broader population.
The sponsor of the drug or therapy, which is usually the pharmaceutical company that developed the product, is required to file the post authorization safety study.
Filling out a post authorization safety study typically involves collecting data on adverse effects, demographic information, and other relevant patient safety information, then submitting it through the appropriate regulatory agency's designated platform.
The purpose of a post authorization safety study is to monitor the long-term safety and effectiveness of a drug once it is in use by the general population, identifying any rare or unexpected side effects.
Information that must be reported includes adverse event reports, demographic data of study participants, results of any additional safety analyses, and comparisons to pre-authorization data.
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