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The amount of sodium contained as an excipient in drugs should be readily available in an understandable format on product labels and package leaflets, the European Medicines Agency says. Read More
The House Appropriations Committee is proposing $2.6 billion in new funding for the FDA, roughly $200 million less than President Barack Obama requested, but no changes to the administration’s proposed user fee levels for drugs and biologics — which total about $1.2 billion. Read More
The Congressional Budget Office is estimating that provisions in the proposed drug overhaul bill, if implemented by the FDA, would cost $872 million from 2016-2020, according to a report issued Tuesday. Read More
Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well. Read More
Orexigen Therapeutics and Takeda filed a patent infringement suit in federal court aimed at blocking Actavis from marketing a generic version of their anti-obesity drug Contrave. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Canadian drugmaker Tekmira has stopped recruiting patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More