Category Archives: Preclinical

The Role of Statistics in Briefing Books for FDA Meetings

Briefing documents are necessary for achieving productive (and hopefully successful) meetings with the FDA. The FDA describes the materials as the “meeting package”; many companies refer to these materials as the Briefing Package, Briefing Document, or Briefing Book (as often the documents are printed hard-copy, bound, and shipped to the FDA for use by their…
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