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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
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
An Indian pharma group contends the U.S. Trade Representative’s scrutiny of India’s intellectual property regime could dampen investment in the country. Read More
A European network of health technology assessment bodies is calling for greater cooperation among HTAs to avoid duplicating work when making decisions about covering drugs in individual EU countries. Read More
A top FDA generic drug official said the agency is implementing various initiatives to improve the way it communicates with manufacturers, including through the revision of an internal document on staff interactions with industry. Read More
Manufacturers seeking approval of biosimilars in Europe will be able to use comparator biologics authorized outside the EU to gain marketing clearance. Read More
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking. Read More