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U.S. Department of Health and Human Services

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Reasoning: 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.

Reasoning:

  Meetings provide an opportunity for sponsors to ask questions about the product application process; the Task Force appreciates the benefits of providing timely answers to sponsor questions.  But meetings consume a significant amount of agency resources, which constrains the number of meetings the agency can hold each year.  FDA strives to meet the goals set forth in user fee negotiations with industry and will continue to assess that process to meet the user fee goals.

For the thousands of meeting requests FDA receives each year, sponsors that follow the agency’s guidance on what is needed to request and prepare for meetings help ensure that the meetings are productive.  Each Center that interacts with product sponsors has developed guidelines for meeting with sponsors.  These documents are currently available on various pages on the FDA Web site.  As a means for improving transparency, FDA will make this information more easily accessible by compiling the information on a central location on the FDA Web site.

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