CDER announced two new efforts to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation based on stakeholder feedback. The efforts include Type C formal meeting requests and pre-ANDA meeting requests, and a pilot study to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply. FDA also proposed a 2018 CDER and CBER staff experiential learning site visit program specific to FDA’s Quality Metrics Program. In a statement, CDER Director Janet Woodcock and OPQ’s Michael Kopcha express confidence that the “efforts will improve both the efficiency and the effectiveness of drug manufacturing, helping to assure a reliable and high-quality drug supply.”
[membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
