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The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain. Read More
Longer-term clinical benefits associated with sustained soliris treatment include prevention of TMA and continued improvement in renal function. Read More
Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
A Form 483 describes the quality problems that led the FDA to ban imports from Ranbaxy’s Toansa, India plant, with investigators troubled by workers retesting samples until they get acceptable results. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
An FDA task force last month recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More