Wednesday, December 23, 2009

Effective Medical Writing for Clinical Submission #6

For medical writing for clinical submission to be effective, lets review submission reminders and points to consider:
  • Know FDA and all regulatory requirements and guidelines to ensure a complete and compliant document
  • Always remember who your end user is - yes, FDA and regulatory agency reviewers, so create a simple, user friendly document
  • Communicate to FDA and others, planned changes that may be used in a document - if different from the standard requirements and guidelines
  • Again, provide user friendly documents that are easily navigated
  • Make sure all bookmarks, hyperlinks, internal (text) and external (linked) to the document are present, correctly linked to content and are active
  • For the CTD Module 2.5, which is the Clinical Overview and for the Application Summary for a NDA, transparency goes a long way, discuss weaknesses in the subject matter and content as well as strengths - be prepared to address both in support of the benefits (risks) of the drug
  • Respect document length (# of pages and # of in text and end of text (EOT) tables, listings, graphs and figures), especially the Clinical Overview - the overview must be ~25 pages summarizing data and interpretation - not a regurgitation of tabular and text table data
  • Ensure appropriate hyperlinking to other CTD Modules 1,2,3,4,5 and/or NDA Sections such as, the ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy).
All clinical submission documents have a respectful, anticipated and expected length - adhere to the requirements and guidelines when determining the length of all clinical submission documents early in the development of the document. The "recommended" length of each clinical submission document can be found at

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