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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
Manufacturers and industry groups are urging the Australian government to drop proposed requirements that would require larger type on drug labels and for labels to be made and applied in a way that prevents their being damaged when the product is opened. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. The standard, ISO EN 27953-2, takes effect July 1. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22. Read More
Indian officials are accusing U.S. Food and Drug Administration investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
The U.S. Food and Drug Administration warned last month 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 European Medicines Agency plans to bar 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
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
The European Medicines Agency has extended a pilot program that allows generics manufacturers to make joint submissions to the agency and regulators in Australia, Canada, Taiwan and Switzerland. Read More
India has finalized the formulas sponsors must use to determine compensation for patients who are injured during clinical trials, and one expert says they will do little to attract trials back to the country. Read More