OR WAIT 15 SECS
November 24, 2015.
In seeking to address industry concerns that providing FDA with specific information on production shortcomings could lead to public criticism and enforcement action, Agency officials are emphasizing that new quality metrics data will be just one factor that FDA uses to assess a facility and drug products.
Russell Wesdyk, acting director of the Office of Surveillance in the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), talked about a “phased approach” for requiring submission of this information at the recent Quality Metrics Conference sponsored by the Parenteral Drug Association (PDA), and emphasized that the data would be used for surveillance, as opposed to enforcement. Over time, he added, the additional information may help the agency identify a “dean’s list” of quality operations that warrant fewer inspections and less oversight of postapproval changes.
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