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The Role in the Lifecycle of a Drug
Medical writing is a specialized discipline that bridges the gap between complex scientific data and the stakeholders who need to understand it. Unlike creative or general content writing, medical writing is defined by precision, evidence, and adherence to strict ethical and regulatory standards.
1. Primary Categories of Medical Writing
The field is generally divided into three major functional areas based on the intended audience and purpose:
Regulatory Medical Writing: Focused on the technical documentation required by government agencies (like the FDA or EMA) to approve new drugs or medical devices. It is highly structured and objective.
Examples: Clinical Trial Protocols, Investigator Brochures, Clinical Study Reports (CSRs), and Common Technical Documents (CTDs).