The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper . The ratings would be publicly available.   “QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for s...