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FDA Delays Quality Metrics Portal

Oct 03, 2017

The U.S. FDA continues to work on its quality metrics portal, though it will not be completed by the anticipated January date. Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA, made the announcement on Sept. 12 at the 2017 PDA/FDA Joint Regulatory Conference during the “Quality Metrics” session, moderated by Amgen’s Steven Mendivil, Senior Advisor, International Quality External Affairs.

Bizjak went on to explain that the Agency is seeking volunteers to test the portal prior to launch. Inquiries can be made to [email protected].

The session also featured Valerie Whelan, Vice President, Corporate Quality, Amgen, who discussed Amgen’s metrics journey. Following the presentation was a panel discussion featuring Bizjak, Alex Viehmann (CDER, FDA), Barbara Allen, PhD (Eli Lilly), Deborah Autor (Mylan), Harry Jeffreys (Catalent Pharma Solutions) and Susan Schniepp (Regulatory Compliance Associates).


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