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Regulations Development - Summary of Public Comments


Transparency Report Arrow Summary of Public Comments


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Comments stated that the agency may publish a proposed rule, solicit comment, and then “is silent for years about whether and when it intends to finalize the document.”  One comment stated that “companies may be confused about what rules and policies to follow in the interim.”  Comments suggested that FDA provide more information about the status of pending rules and urged FDA to publish final rules reasonably quickly.  Comments stated that the rulemaking process should include clear timelines, and if a proposed rule has not been finalized within a reasonable amount of time, FDA should either re-open the comment period for that proposed rule, or re-issue the rule for public comment.

Comments also requested that FDA provide training to industry following the issuance of a final rule.  One comment stated that any training should occur soon after new regulatory requirements are implemented.  Another comment suggested that FDA should issue, on a more frequent basis, questions and answers about new rules.  Industry stated that these actions would help increase understanding of, and compliance with, new requirements.


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