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To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More
The National Institutes of Health has launched a website that it says should help drugmakers plan and implement clinical research across the globe. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing a double-digit increase in the percentage of regulatory restrictions from 2000 to 2012. Read More
The UK’s health care costs regulator is recommending Boehringer Ingelheim’s anticoagulant Pradaxa as an option to treat and prevent recurrent and potentially fatal blood clots in the legs and lungs. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
Indian companies that export active pharmaceutical ingredients to the European Union can use six months of long-term stability data rather than 12 months, under a new rule that relaxes the time period requirement to show conformity with good manufacturing practices standards. Read More
FDA advisors have recommended approval of Daiichi Sankyo’s proposed blood thinner to treat certain patients with atrial fibrillation, putting the Japanese drugmaker one step closer to entering a fierce competition to replace the decades-old treatment warfarin. Read More
A new report from the Italian Medicines Agency says that 10 percent of Italian hospitals experience pharmaceutical thefts, a problem that the European pharmaceutical industry hopes to end with a pan-European verification system set to go live by 2017. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More