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U.S. Department of Health and Human Services

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Product Application Review Process


Background

Summary of Public Comments

Considerations

Transparency Report Arrow View All Product Application Review Process Actions


Actions

Action 7:

FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.

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.

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.

Action 10:

FDA will explain via the FDA Basics for Industry web-based resource how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application.  FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.