Good Summary Judgment

Wednesday, March 03, 2010


Blog Post Summary

  • Provide summaries of attached articles
  • State the relevance of attached articles
  • Give your reviewers one less reason to be grumpy


I just got off the phone with FDA. They asked to pass on a little advice to our clients: If you're going to send articles with your submission please, please send a summary and tell the reviewers how the articles relate to the submission and the sponsor's questions.

Including this information will make the review and discussion go much smoother and ensure FDA can quickly pick up on the points you're trying to make. This is particularly important if the submission will contain numerous articles or references.

This is very similar to the advice I've been giving clients for years. Everyone likes it when work is a little easier than expected. Receiving well-written documents with all of the appropriate information appended always makes me smile – and I just bet it makes FDA reviewers smile, too.

My experience sitting on an IRB has reinforced this point of view. When I start looking at a submission where the protocol doesn't match the consent form or there is missing information I get a little crabby. It also makes me question the overall quality of the work that is going into the project and (I suspect) judge it just a little more harshly.

So, just a little word to the wise (or at least our loyal blog readers): Do your very best to make it easy for your reviewers to understand the points you're trying to make. It's worth the effort.

Tags: 510(k), Best Practices, FDA, FDA 101

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Steve Gutman
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