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Representatives from the Union of Concerned Scientists (UCS) met Aug. 8 with acting FDA Commissioner Andrew von Eschenbach to discuss its recent survey of agency scientists that claimed political and industry interests are influencing scientific decisions.
None of the criteria the FDA’s Office of Generic Drugs (OGD) uses to determine whether it can issue a clinical trial waiver for a generic drug are applicable to ViroPharma’s gastrointestinal antibiotic Vancocin, company executives said July 13.
Several environmental groups have filed a petition asking the FDA to establish health and safety regulations for products containing engineered nanoparticles, which the groups say pose new health risks.
California voters overwhelmingly rejected two proposals Nov. 8 that would have reduced drug costs by either instituting a voluntary program or by forcing companies to lower prices by threatening to pull their products from the state’s Medicaid program.
The FDA has rejected an advocacy group’s citizen petition calling for an outright ban on AstraZeneca’s cholesterol-lowering drug Crestor, which the group claims poses increased health risks compared to other statin drugs on the market.
Not sitting idly by while one of its most successful painkillers prepares for generic launch, Purdue Pharma has petitioned the FDA to withhold final approval for a generic version of OxyContin until generic firms implement appropriate risk management plans (RMPs) and has filed its notice to appeal a recent court decision.