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Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Read More
Morton Grove Pharmaceuticals, a subsidiary of Wockhardt, received a warning letter from the FDA listing GMP compliance issues at its Illinois facility, including insufficient investigations into product instability. Read More
Two senior Democratic congressmen met with President Donald Trump and discussed a bill granting Medicare the ability to negotiate drug prices, which they plan to introduce in the House within the next two weeks. Read More
Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to the agency’s latest performance report. Read More