Medical Writing Plain Language and Readability Regulatory Writing Briefing documents: A case apart
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Volume 24, Issue 1 - Plain Language and Readability

Regulatory Writing Briefing documents: A case apart

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.

References

  1. McIntyre TD, Pappas M, DiBiasi JJ. How FDA Advisory Committee members prepare and what influences them. Drug Inf J 2012;47:32–40.
  2. 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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Regulatory Writing Briefing documents: A case apart
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