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Product Application Review Process - Summary of Public Comments


Background

Transparency Report Arrow Summary of Public Comments

Considerations

View All Draft Proposals for This Topic


Several comments encouraged the use of electronic tools for routine communications between applicants and FDA staff.  Some comments suggested that FDA consistently provide action letters to applicants via electronic communication.  More specifically, one comment suggested that the primary reviewer on a product application should communicate with sponsors through email or telephone if sponsors have questions, or request clarification regarding FDA comments, to avoid delay in the review process.

Comments requested that the agency hold more meetings with the applicant during the review process.  A commenter stated that meetings help ensure an adequate scientific dialogue and common understanding about what is expected during product development and that some meeting requests are not being granted.  One comment suggested that FDA provide sponsors with the opportunity to participate in a mid-cycle review meeting that would highlight issues that arose during the review process.  Another comment suggested that as part of the review process, a regular weekly or biweekly call should be incorporated to provide “timely scientific discipline clarifications as part of the review process.”  The commenter stated that these calls can be cancelled when not needed.  Another comment suggested that FDA offer sponsors the opportunity to participate in a post review meeting.

One commenter noted that not all questions necessarily require a formal meeting or letter for resolution.  A comment suggested that FDA could improve its responsiveness, and decrease the need for full-scale meetings, by developing a process whereby a sponsor may raise and discuss a single issue rapidly and efficiently with the appropriate division.  One commenter requested that the agency engage in more frequent consultations with applicants that are filing applications with FDA for the first time.  One comment called for “informal communications” with FDA through the development and review process so that industry can receive timely answers to clarifying questions.

One comment requested that the agency provide applicants with a better understanding of what information to expect—and when—during the review.  A commenter requested that FDA establish a “clear roadmap for sponsors about what actions will take place, and when, in the review of their application,” another commenter suggested that FDA ensure that major application review milestones are communicated to the sponsor early in the review cycle, and another commenter requested that FDA publish documents that describe procedures for interacting with sponsors during product review.

Other comments suggested that FDA develop an electronic system that would allow sponsors and applicants to track their application through the review process.  Comments noted that this system may help eliminate redundant questions from sponsors and applicants regarding the status of their application.

Some comments noted that this system should only be developed if it could maintain the security of information contained within the system.  As stated by one commenter who suggested FDA consider developing a tracking system, “given the importance of protecting competitive and confidential commercial information, it is imperative that such a system provide access only to the sponsor and be operated under strict security guidelines.”  Other comments noted that FDA should provide more clarity regarding the status of product reviews and include specific timelines in responses sent to industry.

To maintain continuity of any communications between FDA and industry, comments stated that FDA should inform sponsors, especially when they have an application pending, about any changes in personnel within a FDA division.

Several comments requested more information about the process the agency uses to assure consistency of the review process.  One comment requested that FDA provide review staff, especially project management staff, with training in communication during review of applications.

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