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Just as the U.S. Food and Drug Administration is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information. Read More
The FDA handed Gilead Sciences an eight-observation Form 483 for an array of production issues, including poor manufacturing instructions and processing procedures. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
CDER plans to spread drug company inspections across three of its offices — the Office of Regulatory Affairs, Office of Pharmaceutical Quality and Office of Compliance — rather than conduct all inspections through OPQ, center officials said Wednesday. Read More
After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license. Read More
A recent survey showing that drug company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
Toronto-based active pharmaceutical ingredient maker Attix Pharmaceuticals received an FDA warning letter due to lapses in current good manufacturing practices, including failure to appropriately package drug products to avoid cross contamination. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Following a series of setbacks that included two failed preapproval inspections and 24 citations, Hospira says the FDA has signaled the all-clear for its new Visakhapatnam, India, manufacturing facility and production is underway. Read More