RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • FDA Finalizes Guidance on 'Dear Healthcare Provider' Letters

    The US Food and Drug Administration (FDA) has released a final guidance that aims to clarify the agency's requirements for information contained within "Dear Healthcare Provider" (DHCP) letters. Background The letters-so-named because they often begin with that exact salutation-are usually bulk mailings sent out by a manufacturer when it has been made aware of a serious problem with a drug or biologic, or when there is a need to provide updated information to the health...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...
  • 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 ...