Periodic Safety Update Reports (PSURs) in Pharmacovigilance: A Complete Guide
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an evaluation of a drug’s benefit-risk balance at defined intervals post-authorization. PSURs help regulators, sponsors, and healthcare providers understand the evolving safety profile of a medicinal product, ensuring that the benefits continue to outweigh the risks over time.
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