By Dr. Diane Mauriello Ph.D., Dante Resouces, Inc.
Submission reminders and points to consider for effective medical writing for a clinical submission
In 2007, the FDA released draft guidance to the industry pertaining to governance, compliance, safety,
effectiveness, substantial and certifiable equivalence data included in clinical submissions. Since then there have been numerous discussions, forums, conferences and working sessions with FDA to resolve concerns pertaining to high risks to patient safety. The delay has impacted companies that are prepared with applications and clinical submissions and ready with go-to-market IVDMIA (Invitro Multi-Variant Index
Assays) strategies, final products and kits. IVDMIAs use molecular and non-molecular markers to produce a diagnostic value.
To avoid potential delays and related high costs it is important that companies thoroughly understand the role of the FDA and all regulatory requirements and guidelines in order to ensure a complete and compliant document.
Keeping the following checklist in mind can help the submissions team to keep in focus and maintain the time lines and necessary checks and balances.
- Always remember who the end user is - the FDA and regulatory agency reviewers. Your team will be best served by creating simple, user friendly documents that are easily navigated.
- Communicate to the FDA and the reviewer any and all planned changes that may be used in a document - if different from the standard requirements and guidelines.
- 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 an NDA, transparency goes a long way. Discuss weaknesses in the subject matter and content as well as strengths. You must be prepared to address both in support of the benefits (risks) of the test.
- Be aware of the document's length (# of pages and text and end of text (EOT) tables, listings, graphs and figures). In particular the Clinical Overview must be ~25 pages summarizing data and interpretation - not a rehash of tabular and text table data.
- Ensure appropriate hyperlinking to CTD Modules 1, 2, 3, 4, 5 and NDA Sections such as the ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) are active.