Skip to content

Regular Sections

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

Back To Top
Your Cart

Your cart is empty.