ANDA Review Consistency Could Emerge As A GDUFA Problem
Executive Summary
Industry officials are concerned all the new FDA hires to handle generic drug user fee program issues will lead to varied interpretations of agency policy and potentially create first-to-file or other problems.
You may also be interested in...
Gottlieb Highlights Drawback To Increasing FDA Salaries: Resource Disparity
FDA commissioner tells agency stakeholders that there could be intra-agency moves to centers and offices that can offer higher pay.
Gottlieb Highlights Drawback To Increasing US FDA Salaries: Resource Disparity
Commissioner tells agency stakeholders that there could be intra-agency moves to centers and offices that can offer higher pay.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.