• RF Quarterly

    Medical writing strategies: Aligning regulatory documents with strategic goals

    This article provides some best practices to align regulatory documents with strategic goals, allowing regulators to understand what a sponsor is trying to achieve, why this goal is important, and how the totality of available information supports the desired regulatory action. Adopting the perspective of a regulatory agency audience, using clear structure and language, and leading teams skillfully are key elements of successful regulatory medical writing.   Keywords ...