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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
A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Read More
The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic Research Labs’ facilities in India. Read More
FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016. Read More
Australia’s TGA 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
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that 10 percent of them are substandard. Read More