Focus on Pharma: FDA's Friedman Urges Better Supplier Oversight and Investment in Quality; Any Questions? Call Me, says FDA's Rothman
Understaffing quality operations, failing to oversee suppliers and contractors, and blaming problems on mid-level QC and manufacturing managers, is not the answer. At a summer conference on GMP's, FDA's Rick Friedman and colleagues Barry Rothman and Steven Wolfgang, discussed the roots of current supply shortages, and emphasized the need for proactive communication with the Agency and its district offices. They also responded to criticism on the way the Agency's handling inspections.