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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
A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug. Read More
Drugs containing the antihistamine hydroxyzine should be taken at the lowest effective dose for the shortest possible time to minimize heart risks, a drug safety committee in the EU says. Read More
The FDA last week granted final approval to Mylan and Watson for generic versions of Pfizer’s blockbuster arthritis drug Celebrex, allowing the companies to share 180-day exclusivity with Teva. Read More