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FDA’s New ‘Site Engagement’ Program Aims To Avert Quality-Related Drug Shortages

 
• By Bowman Cox

US FDA office that surveils drug manufacturing facilities invites sites on the cusp of failure for “engagements” in which they talk about how to turn things around. The agency says there’s no pressure – these site engagements aren’t enforcement actions and they’re completely voluntary.

Compliance

The Office of Surveillance in the US FDA’s Office of Pharmaceutical Quality has launched a program to work with drug manufacturing facilities that may be at risk of causing quality-related drug shortages, agency officials told the recent 2018 International Society for Pharmaceutical Engineering annual meeting in Philadelphia.

“It’s a voluntary program to encourage quality practices at FDA-selected manufacturers with the goal of ensuring availability of quality pharmaceuticals,” Tara Gooen Bizjak of OPQ’s Office of

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