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President Barack Obama Wednesday signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
Twenty-five drugmakers have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds improperly paid out to drug companies. Read More
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid & Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. An ad developed by the company for its anemia drug Aranesp omitted risks and inflated efficacy claims, the agency says. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
Drugmakers that face multiple disputes with doctors over payments reported to the Centers for Medicaid and Medicare Services (CMS) under the Physician Payment Sunshine Act will likely face an audit by the agency. Read More
Chinese authorities are gearing up to keep the cost of certain drugs sold in the country down via publication of a “low-cost” drug list expected to expand access to generics. Read More