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Medical writing for generics throughout the life cycle

Authors: Sandra Götsch -Schmidt

Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to be composed, preferably by or with the help of a medical writer. This article aims to familiarise the reader with the usual terminology and relevant guidelines. Key documents throughout the entire life cycle of generic medicinal products are described, starting with the clinical documents during the development process, continuing with required support for the authorisation process, and concluding with post-marketing material.

Medical Writing. 2019;28(2):39–44

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