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The European Medicines Agency is reviewing data related to studies performed by Micro Therapeutic Research Labs at two sites in India, following a clinical practice inspection. Read More
The FDA finalized guidance on suspect products and notification, describing when to file a report and adding examples of fraudulent activity that would warrant an alert to the agency, trading partners and wholesale distributors. Read More
The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More
Global drug spending will climb to $1.5 trillion in the next five years, marking a nearly 32 percent increase, fueled largely by new medicines and emerging markets. Read More
The European Medicines Agency made several changes to a guidance explaining the agency’s policy for publishing clinical trials data and factors that could lead to rejection. 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