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Members of the House Energy & Commerce Committee are giving the FDA until Aug. 14 to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency. Read More
Takeda’s diabetes drug Actos, which has caused the company to pay nearly $2.4 billion to settle lawsuits over cancer risks, did not increase the risk of bladder cancer in a large postmarketing study, the drugmaker says. Read More
Beleaguered Indian companies continue to stumble when it comes to quality issues, with generics maker Wockhardt conducting yet another recall, and active pharmaceutical ingredients makers Mahendra Chemicals and Nosch Labs racking up GMP deficiencies. Read More
Inadequate investigations and corrective and preventive actions have been one of the top reasons for 483 observations since 1997, says James Vesper, president of LearningPlus. A 30-year veteran in the pharma business, Vesper talked with FDAnews about how to develop a successful CAPA program to uncover root causes of quality failures.Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
This past month, FDA zapped seven more compounders in Tennessee, California, Florida, Arkansas, Montana and Washington over sterility issues. The FDA handed out three warning letters, three Form 483s and one facility issued a recall following an inspection. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More