HELP Committee Leaders Aim To Prevent Controversial Add-Ons To User Fee Bill
This article was originally published in The Gray Sheet
Members of the Senate HELP Committee expressed concerns that potential riders added to the FDA user fee bill could slow down passage and add more work for FDA staff.
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Agency’s device center holds many reviewers to user fee pre-market time goals as part of employee performance reviews, but the goals are not explicit components of the CDRH director’s performance plan, an inverse approach to that of FDA’s drug center, according to the Government Accountability Office.
Details on draft legislation circulating in the House and Senate.
The agency published its draft commitment letter and draft legislative language for user fee reauthorization March 15. A public meeting is set for the end of the month, and public comments will be accepted through April 16.