January 2015

26
Jan

Coach K Gets 1000 Wins and FDA Gets Califf from Duke

Dr. Robert Califf was appointed FDA Deputy Commissioner for Medical Products and Tobacco. As such, Dr. Califf will oversee the “Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.”

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13
Jan

Office of Pharmaceutical Quality Standing on Own Two Feet

Well, it’s January 2015 and the Office of Pharmaceutical Quality (OPQ) is about to be stood up (“FDA speak” for official) and will be addressing quality issues across the New Drugs and Generic Drugs arenas. The concept is of one quality voice and one standard, but more about this in a bit. The new leaders of OPQ are outlined in a CDER posting relative to the new organization.

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06
Jan

New or Revised Guidances to Look for from FDA in Calendar Year 2015

FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.

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