PDA is working with FDA to confirm the participation of several other CDER officials and with the UK's Medicines and Healthcare Products Regulatory Agency to confirm one of their officials. The conference also will have broad industry and academia participation, including speakers from Amgen, Johnson and Johnson, Sanofi Pasteur, Hovione, the University of St. Gallen, and many others.
The meeting is the first chance for industry representatives to hear from and interact with FDA officials following the Agency's publication of a revised draft of Submission of Quality Metrics Data Guidance for Industry. Public comments on the document were originally due in January, but FDA recently announced an extension of the public commenting period to March 27. The extension of the commenting period signals FDA's desire for as much inclusive feedback as possible, and its participation in this meeting is perfectly timed for receiving that input and having a direct dialog on the draft.
Registration for the conference is open.
Members of the press can request passes using the online press pass form.
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SOURCE Parenteral Drug Association