PDA Quality Metrics Task Force to Comment on U.S. FDA Metrics Draft Guidance 1 December, 2016

PDA conference first chance for industry to hear from/question FDA about guidance

Bethesda, Md., November 30, 2016 – The Parenteral Drug Association (PDA) is preparing comments on the U.S. FDA’s revised draft guidance for industry: Submission of Quality Metrics Data.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, 2017, at the Bethesda North Marriott Hotel & Conference Center, Bethesda, Md., will provide industry representatives the first chance to ask FDA officials who are involved with developing the metrics guidance/program, including Tara Gooen Bizjak, the contact person for the current draft.

“PDA is committed to providing science-based commentary on the quality metrics draft guidance, as we did with the release of the first draft in 2015,” said Richard Johnson, PDA president.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 U.S. FDA called on industry participation in 2013.”

More information on the conference is available here. Members of the press can request a pass using PDA’s online form.

PDA’s comments on the first draft of the quality metrics guidance are available here.