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The FDA wants to refine the methods it uses to assess patient perception of risk and benefit information in direct-to-consumer advertising, aiming to design more accurate DTC ad studies that don’t overtax the subjects. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this month. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
Inspections of U.S. pharmaceutical manufacturing facilities have seen a declining number of official warnings over the past five years, but the trend is less clear on the international front. Read More
Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More
Generics firm Pliva has asked the U.S. Supreme Court to throw out a decision by Iowa’s highest court that potentially paves the way for the company and other generics makers to be held liable in failure-to-update-label claims. Read More
British generic drugmakers want branded generics to be exempt from any further price cuts on brand pharmaceuticals, arguing their products already deliver greater savings than what can be achieved from government intervention. Read More
The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
The head of the European Medicines Agency was forced to resign after a tribunal found he was improperly selected in 2011, a move agency officials characterized as a procedural issue. Read More
The drug pricing authority of India is calling on industry, public health experts and others to help update the country’s list of life-saving and essential drugs, a move that one observer says is needed to understand which drugs are on the market and under price controls. Read More
The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the products. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More