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PDA Presents its Perspective on the US FDA Quality Metrics Draft Guidance at Public Meeting

For Immediate Release:
08/24/2015
Media Inquiries:
Walter Morris
/ morris@pda.org /
301-656-5900, x. 148

Bethesda, Md., August 24, 2015 – The Parenteral Drug Association (PDA) today presented its perspective on the U.S. FDA’s draft Request for Quality Metrics Guidance for Industry at a public meeting at FDA’s White Oak Campus in Silver Spring, Md.

PDA President Richard Johnson addressed the U.S. FDA on behalf of the Association and its Quality Metrics Task Force of volunteers. Among its recommendations, PDA believes a company's quality culture is critical, but cannot be easily assessed through metrics. Trending of metrics within a site/company/products is preferable to direct comparison between sites/companies/products. FDA might consider adding a "right first time" metric in the future. PDA will include all the recommendations covered by Johnson and other recommendations, in its written comments on the draft guidance, which are due to the Agency in September.

"We are pleased that the U.S. FDA continues to offer extensive opportunities for industry to participate in this ongoing endeavor to develop a quality metrics program," said Richard Johnson after his remarks. "PDA has led a number of key initiatives in this area, including working with the U.S. FDA to sponsor several information-gathering workshops, conducting a comprehensive industry survey on quality culture in 2014, and publishing a Points to Consider on Pharmaceutical Quality Metrics last year."

PDA will publish the results of the 2014 quality culture survey in September and is holding a third Pharmaceutical Quality Metrics Conference November 9-10 in Bethesda, Md.