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Guidance Development - Summary of Public Comments


Transparency Report Arrow Summary of Public Comments


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Many comments from industry stated that improvements are needed to the agency’s guidance development process.  Several comments stated the timeliness of the process must be improved, noting that “the process moves too slowly to provide meaningful information to industry.”  Some comments suggested that FDA formally track the agency’s progress in drafting guidance documents, and include clear timelines and specific development stages.  Comments further noted that if the guidance development process is delayed, stakeholders should be notified.  Industry also requested that FDA inform stakeholders about the priority of guidances that the agency is planning on working on during the year.

Comments suggested that FDA create more opportunities for feedback from stakeholders during the guidance development process, including outside of the formal notice and comment mechanism.  Comments suggested that once the agency receives input on a draft guidance document, FDA establish a transparent procedure for describing how it has evaluated those comments.

Comments suggested that for guidance documents that have been in draft form for a specified period of time, e.g., longer than five years, FDA should reissue the guidance for public comment, so that the final draft reflects the most current knowledge of the subject matter and the guidance continues to be relevant.  Comments also requested that FDA develop and communicate a work plan to finalize guidance that has been in draft form for many years.

Comments suggested that training and education should be part of the agency’s guidance implementation process.  Suggestions included holding public workshops where FDA employees review new guidances, holding webinars that allow for open public participation, and issuing question and answer documents about the guidance.  Comments noted that training should occur early in the implementation process, preferably soon after a new policy or process is implemented.

Comments also requested that FDA issue more guidance documents.

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