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The FDA has been asked to turn over a trove of information related to the development of its proposed generic drug labeling rule, with GOP leaders of a key House investigative committee claiming the agency engaged in “dubious” behaviors in the rulemaking process. Read More
Companies exporting drugs from India were supposed to include barcodes featuring identification codes and serial numbers on all primary-level packaging by July 1, but the union government has postponed that date indefinitely. Read More
The FDA delivered its fifth warning letter to a compounding pharmacy in roughly two weeks, admonishing a Texas compounder for poor aseptic processing of sterile drugs. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More
A New Jersey drug coating company hasn’t paid its generic drug facilities fees for the last two fiscal years, making every product it helps to manufacture automatically mislabeled, the FDA warned. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More