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U.S. Department of Health and Human Services

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Reasoning: Action 9

FDA will communicate on the web-based resource, FDA Basics for Industry, general expectations about the circumstances, if any, under which it is appropriate to use secure email between FDA and a manufacturer when there is a question involving the manufacturer’s product.

Reasoning:

FDA appreciates the potential efficiencies associated with the use of electronic communication.  But, product applications submitted to FDA include proprietary information that should not be disclosed to the public.  As a result, communications about product applications via electronic means must be conducted in a fashion that maintains the security of this information.

In some instances, Centers have established a means for sponsors to communicate about product application related matters via secure email, if they choose to do so.  In these cases, there are processes governing the use of secure electronic communication.  Each Center’s practice with respect to the use of electronic tools to communicate about product applications will be explained and made readily available on the FDA Web site. 

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