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The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
The proprietary name of a drug should include either the International Non-Proprietary Name or a description of its effects, and should be consistent across the product’s range, according to revised guidance from South Africa’s Medicines Control Council. Read More
India’s medicines authority has released a set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Australia’s research-based drug companies are urging the government to accept product approvals by trusted regulators in the U.S., EU, Canada and the UK with only minimal in-country review to speed access to breakthrough treatments. Read More
Global drug regulators have reduced drug approval times over the last 10 years, and while the U.S. Food and Drug Administration remains the fastest at approving new drugs, other regulators are closing the gap. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More