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Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. Read More
A federal appellate judge has ordered brand firm Endo and generics manufacturer Mylan to continue negotiating a court-mandated settlement that will allow Mylan to market a generic version of Endo’s migraine drug Frova. Read More
The FDA yesterday approved an expanded indication for Janssen and Pharmacyclics’ blood cancer drug Imbruvica to treat chronic lymphocytic leukemia patients who carry a deletion in chromosome 17, which makes them resistant to standard CLL treatments. Read More
In a significant shift in its electronic submission policy, the FDA will require drugmakers to submit certain drug master files and all advertising and promotional materials electronically by 2016. Read More
Manufacturers of nonprescription drugs sold in Australia have until Dec. 20 to include statements on specific risks in the product labeling, according to the Therapeutic Goods Administration. Read More
The UK’s healthcare costs watchdog is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending that doctors prescribe three new generation anticoagulants rather than commonly used warfarin or aspirin. Read More
A loophole in the oversight of active pharmaceutical ingredients and an inconsistent reporting structure are just some of the challenges the U.S. Food and Drug Administration faces in improving drug quality in China, according to the agency’s top official there. Read More
The European Medicines Agency’s Committee for Advanced Therapies has clarified when drugs may be classified as advanced therapy medicinal products, including the criteria for classifying cells and tissues as engineered. Read More