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Drugmakers have 13 months to revamp how they track drugs after President Barack Obama signed into law a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
UK-based Egalet has signed a licensing agreement with Shionogi to develop and market oral abuse-deterrent hydrocodone opioid products, with Shionogi footing the bill for all development costs and holding on to global marketing rights. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction nor postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying Square Pharmaceuticals’ citizen petition requesting a waiver and change to GDUFA’s statutory language. Read More
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