Section Editors: Clare Chang, Zuo Yen Lee

 Briefing documents: Facilitating health authority interactions

Author: Clare Chang

 Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities like the US FDA and EMA, provide critical information necessary for obtaining scientific advice throughout drug development. These documents encompass product background, development status, regulatory interactions, and specific questions from Sponsors, significantly influencing regulatory decision-making. The complexity of briefing documents varies based on development stages, requiring detailed preparation by medical writers to ensure clarity and relevance. Successful interactions rely on effective collaboration, flexibility, and thorough docu mentation of outcomes, enabling Sponsors to make informed decisions and continuously refine their clinical development programmes based on health authority feedback.

 Medical Writing. 2025;34(2):112–115. https://doi.org/10.56012/ucdt2648