Recent Reflections

Monday, November 16, 2009

We've had numerous meetings with FDA in the past few months on a number of different products. Some of these meetings have produced new revelations, but others have served to underscore the importance of regulatory fundamentals.  

As important as it is to keep up with the latest thinking in White Oak, it's every bit as important to attend to the more mundane details that can help or hinder an application.  In no particular order, here are some common themes that have emerged in several recent meetings.

Express Yourself
When it comes to submissions, writing quality is critical. Accuracy is the most important element of submission quality. Documents that are not clear or contain errors are not impressive and will not represent your science well. Even though we are all subject to deadlines, sacrificing accuracy for speed is the wrong choice. Review, review and review again!

They're Called Standards For a Reason
Follow guidelines wherever possible. CLSI is your best friend. Don’t re-invent study designs unless absolutely necessary. Start with established methodology and vary it based on product needs – not the other way around.

Curiosity is not an Intended Use
FDA will not accept an intended use that is just measurement. Whether your product is useful in monitoring cancer or predicting neurological disease, measurement of gene expression, proteins or whatever needs to be linked to a medical condition. It’s critical to show FDA what a physician will do with the information and how it will effect patient care.

Disclosing too much information is almost always a better approach than disclosing too little. I understand caution and reluctance when it comes to sharing information with the FDA.  That said, companies tend to favor an overly conservative level of disclosure in almost all cases. If a company withholds important information about a product, study designs, or samples to be used than FDA cannot comment or offer what may be critical advice.

Eventually, FDA is going to see this data before you will have your clearance.  Sharing now might help you avoid sinking time and money into a strategy that FDA could have warned you against.  FDA needs to understand the work that you are doing if they are going to give input.
Check your website. FDA is sending out compliance letters. Most of these are going out as untitled letters that means they are not public. Many of the letters are based on information found on the company website. Your competitors can see your website, too – and many companies make a habit of turning in anyone that seems to be taking an overly liberal approach to advertising. In particular, advertising RUO products with clinical intended uses will get you noticed.

Tags: FDA, FDA 101

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