Category Archives: Biostatistics

Rare Diseases Well Done!

It has been ten years since the FDA released rare disease guidelines for sponsors seeking FDA approval. Once a drug or biologic candidate has been identified for study, an execution strategy is needed not to only bring the candidate to regulatory approval, but to also facilitate post-approval acceptance and adoption of the new product among…
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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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Biostatistics’ Challenges in Orphan Indications

The role of biostatistics in drug development has been evolving since the 1962 Kefauver-Harris drug amendments. Those legal amendments were driven by the poor state of clinical trial research that had been conducted in prior decades as well as the outcomes from numerous safety failures of existing products at the time. The new regulations included…
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