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Regulatory Writing Briefing documents: A case apart
Authors: Gregory Morley
Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice, and protocol assistance) with health authorities. These interactions can shape the clinical development of a product and as such are clearly of great importance to companies. A well-written and presented briefing document may be crucial, or at the very least, can smooth the path to the desired outcome.
Medical Writing. 2015;24(1):41–42

