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PDA to Comment on Revised FDA Metrics Guidance

Jan 03, 2017

Metrics Conference Offers First Chance to Hear from FDA

PDA is preparing comments on the U.S. FDA’s recently revised draft guidance for industry: Submission of Quality Metrics Data. The revised draft was issued after strong public interest and comment on the first draft, which was published in 2015.

The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference, Feb. 21–22, in Bethesda, Md., will provide industry representatives an opportunity to interact with FDA officials involved with developing the metrics guidance/program, including the U.S. FDA’s Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, the contact person for the current draft.

“PDA is committed to providing sciencebased commentary on the quality metrics draft guidance, as we did with the release of the first draft in 2015,” said Richard Johnson, PDA President. “The quality metrics/culture conference will be the fourth held by PDA on this important topic since the FDA called for industry participation in 2013.”

Learn more about the 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference!


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