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The goal of the ICMRA would not be to develop identical standards, but to provide the public with “high-level, strategic advocacy” around quality, Hamburg said at a recent conference in London hosted by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA March 12 banned imports to the U.S. from two more Indian manufacturers, ratcheting up the pressure on the country’s domestic drugmakers to improve product quality. Read More
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
Dr. Reddy’s Laboratories is the latest Indian drugmaker beset by quality problems after recalling 58,650 bottles of the generic heartburn drug lansoprazole due to contamination. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, the Central Drugs Standard Control Organization said Feb. 13. Read More
The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
The U.S. Food and Drug Administration and European Medicines Agency have launched a new information-sharing initiative aimed at speeding international responses to drug safety problems. Read More
The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
Australia’s Therapeutic Goods Administration (TGA) said Tuesday it is evaluating the potential safety risks of Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma occurring in patients using the drug. Read More