Volume 24, Issue 1 - Plain Language and Readability
Regulatory Writing Briefing documents: A case apart
Author: Gregory Morley
Abstract
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.
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References
- McIntyre TD, Pappas M, DiBiasi JJ. How FDA Advisory Committee members prepare and what influences them. Drug Inf J 2012;47:32–40.
- Ciociola AA, Karlstadt RG, Pambianco DJ, Woods KL, Ehrenpreis ED. FDA-Related Matters Committee of the American College of Gastroenterology. The food and drug administration advisory committees and panels: how they are applied to the drug regulatory process. Am J Gastroenterol 2014;109:1508–12.
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