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President Barack Obama signed the 21st Century Cures Act into law during a White House ceremony Tuesday, following over two years of work on Capitol Hill. Read More
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
Japanese drugmaker Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues. Read More
As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers. Read More
Indian drug regulators in seven states have accused 18 drugmakers of selling substandard therapies after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities of active ingredients. Read More
Drugmakers have expressed concern about the German government’s proposal to restrict drug pricing — contending that the measure penalizes research and development. Read More
The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Read More
After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More