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U.S. Department of Health and Human Services

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Reasoning: Action 3

Each Center has a process for industry to submit general regulatory questions, and for directing inquiries to individuals with additional expertise, if necessary. Links to these processes will be made available on FDA Basics for Industry.


It is important to provide a clear mechanism for industry to ask questions about the regulatory process and receive answers.  While each Center has telephone lines and email inboxes dedicated to this purpose, the Task Force received several comments requesting that the agency develop a system to answer questions from industry.  The Task Force concluded that the agency does have the system in place but must make this information more prominent and accessible.

FDA has now instituted standardized email addresses for industry to submit questions about FDA-regulated products.  The email addresses are standardized according to product type.  The addition of these standardized email addresses does not disrupt the functionality of other email addresses that accepted questions from industry in the past.

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