The proposals will published in the May 21, 2010, Federal Register and are part of the second phase of the FDA’s Transparency Initiative launched last summer, according to the release.
The proposals reflect the review of more than 1,500 public comments received by the FDA after two public meetings held by the task force and extensive consideration and discussion within the agency, according to the release.
The 21 proposals cover areas including adverse event reporting, docket management process, enforcement priorities and actions, import procedures, inspections, product applications, recalls and warning and untitled letters.
The FDA is seeking public comments on the proposals in the draft report for 60 days.
Read the FDA’s release on its draft transparency proposals.
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