FDAnews Drug Daily Bulletin
June 6, 2012 | Vol. 9 No. 111
Despite recurring pharma quality problems, drugmakers are still inclined to meet minimum manufacturing standards set by regulators, rather than make quality central to their business model.
The U.S. Food and Drug Administration (FDA) and other agencies must provide expertise, training and tools to developing nations to improve their pharma monitoring practices and prevent dangerous drugs and medical products from entering the U.S., according to an April 4 Institute of Medicine (IOM) report.
FDA statistics show more than one-third of all drug recalls last year were due to stability failures — a figure that suggests the generic industry’s call for stability testing flexibility in a forthcoming guidance is unwarranted, agency officials say.
Targacept Chief Executive J. Donald deBethizy is resigning for personal reasons as the drug-development company struggles to overcome a series of setbacks in its experimental pipeline.
Officials were called to a pharmaceutical plant in Johnston County Tuesday morning after a reported acid spill.
The Indian government has initiated a process to reduce Indian drug industry’s growing dependence on China for raw materials, including the critical penicillin, which is needed to manufacture most of the anti-infective drugs.
Pfizer is to let 180 workers go at its two Cork plants in Little Island and Ringaskiddy.
Teva Pharmaceuticals’ plans to build a facility in Northeast Philadelphia now appear uncertain, as the drugmaker goes through tumultuous change at the top of its global organization.
Merck said its experimental insomnia drug maintained effectiveness for 12 months in a late-stage study, the first sleep aid ever tested for a full year, and reaffirmed its plans in 2012 to seek marketing approval for the medicine.
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