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The FDA has slapped India’s Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More
A California supplement maker is in hot water after being accused of making drug-like claims about its products and relying on improper production methods. Read More
Following a safety review, the FDA has added additional warnings to the labels of SGLT2 inhibitors for diabetes because they can cause the body to produce too much acid in the blood or lead to serious urinary tract infections. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they found 27 critical findings, 169 major and 155 minor findings. Read More
The FDA is asking Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
Drugmarkers are reporting a 20 percent improvement in securing their supply chains compared with a year ago, according to findings from a new report. Read More
A House committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More