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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The FDA has withdrawn approval of 13 NDAs, including for drugs to treat pain and hypothyroidism, after the manufacturers repeatedly failed to submit mandatory annual reports on the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
The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More
Drugmakers can now access all regulatory advice on regenerative medicines in the UK through a single web portal, thanks to a government initiative launched Oct. 13. Read More
The Australian government plans fast-track approvals and joint drug reviews with other countries, following an independent review aimed at making the drug approval process less redundant and easier to understand. Read More
Australia’s medicines authority is urging tougher warnings on the cardiovascular risks of over-the-counter nonsteroidal anti-inflammatory drugs, as well as new initiatives to inform patients about the risks associated with both OTC and prescription versions of the painkillers. Read More
Access to a forthcoming clinical trials portal and database would be limited to authorized users and “super users,” under draft specifications released by the European Medicines Agency.
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