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.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.