Feature Articles
Postmarketing safety writing: Communicating drug safety beyond approval
Authors: Shilpi Mittal
Postmarketing safety writing plays a vital role in the ongoing evaluation of drug products after marketing authorisation. This article explores the objectives, regulatory frame work, key deliverables, and best practices associated with postmarketing safety documentation. From adverse event narratives and Periodic Benefit-Risk Evaluation Reports to Risk Management Plans, postmarketing safety writing is fundamental to maintaining the benefit-risk balance of medicinal products. With growing demands for trans parency and harmonised global regulations, medical writers must adapt to evolving expectations in pharmacovigilance reporting.
Medical Writing. 2025;34(4):14–18 | https://doi.org/10.56012/ocig7086
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