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  • FDA Seeks to Broaden Collection of Prescribing Data in Bid to Track Use, Safety of Drugs

    US regulators are laying the groundwork to potentially monitor the use of drugs by patients discharged by healthcare facilities, mirroring and expanding upon other planned activities. Background In June 2013, the US Food and Drug Administration (FDA) announced that it was seeking access to data on adult and pediatric utilization of drugs used in inpatient and emergency settings. The intent, FDA said, was to better conduct postmarket surveillance on the safety of phar...
  • DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

    The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...