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Guidance Development - Considerations


Background

Summary of Public Comments

Transparency Report Arrow Considerations

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The Task Force agrees that it is critical that the agency provide relevant, timely guidance to industry in order to support efforts by industry to comply with the law and develop new products that may benefit the public health.  The Task Force recognizes that the current guidance development process can be opaque, issuance of final guidance documents can be slow, and this can have negative effects on industry and the public.

In part because of competing, sometimes higher-priority, demands on agency staff, there are no simple solutions to such problems as lack of predictability about when a guidance document will issue.  For example, if application review, regulation development and crisis management are all given a higher priority than guidance development, and the same staff are responsible for all of these activities, it may be impossible to predict when guidance documents will be completed.  In addition, many of the problems, such as timeliness, cannot be addressed solely by greater transparency.

The Task Force considered the importance of providing clearer expectations about the guidance development process and better support for efforts by industry to satisfy agency recommendations.  The Task Force considered the existing processes used to manage the guidance development process.  The Task Force also considered the substantial resource issues involved in improving guidance development.  The FDA staff who are responsible for guidance development are generally the same staff who are engaged in other agency priorities such as application review and regulation development.

The Task Force considered the effectiveness of the agency’s current guidance development methods to provide useful and timely advice to industry.  The Task Force agrees that the timeliness of issuing final guidance documents is an area in need of improvement

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