Drug Shortages: FDA Says Market Must Reward Production Quality
Executive Summary
FDA officials state in journal article that manufacturers are not incentivized to ensure quality and base competition entirely on price.
You may also be interested in...
US FDA Opens Next Round Of Quality Metrics Debate With New Menu Of Options
Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.
Drug Shortage Plan Would Grade Firms To Encourage High-Quality Production
US FDA task force recommends a rating system that purchasers could rely on to reward manufacturers with robust management systems.
FDA Inspectors Focusing Attention On Traditional Manual Aseptic Filling Lines
Firms that manufacture sterile drugs on traditional filling lines instead of using restricted access barriers or isolators risk tighter scrutiny from FDA inspectors, agency official says. Yet it remains unclear how much of a difference the increased oversight will make.