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U.S. Department of Health and Human Services

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Reasoning: Action 8

As part of the FDA Basics for Industry web-based resource, FDA will describe the types of notifications it provides to industry (e.g., letter acknowledging receipt of the application, mid-cycle review meetings) associated with the product application review process.  FDA will explain its practice of providing the sponsor with the name and contact information of the individual who should be contacted with questions about the product application.  FDA will provide an overview of the processes used to strive for consistency of product application review.

Reasoning:

Explaining the product review process may give industry information that is helpful for business planning purposes and may lead to efficiencies in the review process.  Providing this information in an easily accessible format may decrease the need for industry to contact FDA for this information and the need for more resource-intensive meetings.

Each Center has a process by which it reviews product applications that are submitted to the agency, and works to complete the review process in an efficient and timely manner.  Each Center also has a process in place to strive for consistency of product application review; explaining this process may increase understanding of the agency’s decision-making process.  FDA’s product application process will be summarized and made more easily accessible by compiling the information on a central location on the FDA Web site. 

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