FDA Employee Assessments Don’t Always Include User Fee Performance Goals
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
HELP Committee Leaders Aim To Prevent Controversial Add-Ons To User Fee Bill
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.
Belgium Aims To Drive Biologic Competition Through Tendering
New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.
EU Bodies Agree On Ways To Future-Proof EMA Funding System
EU ministers say that implementing an appropriate fee structure that is more in line with actual costs will promote innovation in the pharmaceutical sector while ensuring “fair access” to safe and effective medicines for patients.