Regulatory and Washington

  • FDA withdraws draft guidance on biosimilars
    Key factors in the decision included comments noting that the number of reference product lots biosimilar developers would need to purchase under the draft guidance if it were finalized could impact cost and efficiency.

  • Florida's drug price transparency law takes effect
    Pharmacists in Florida can now share cost information with patients, thanks to a new law that took effect July 1.

  • NACDS, WSPA and NCPA file legal brief in Washington’s Medicaid lawsuit
    The National Association of Chain Drug Stores, Washington State Pharmacy Association and the National Community Pharmacists Association filed a key legal brief with the Washington State Court of Appeals that challenges the state’s refusal to reimburse community pharmacies for the cost of providing care and services to disadvantaged Medicaid patients.

  • House passes opioid bills package
    The legislative package focused on opioid abuse included the NACDS-backed Every Prescription Conveyed Securely Act, which would require controlled substances under Medicare Part D to be prescribed electronically.

  • FDA expands approval of diabetes management device for younger pediatric patients
    The U.S. Food and Drug Administration has expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes.

  • FDA approves first CGM system with implantable sensor, mobile app
    The U.S. Food and Drug Administration has approved the Eversense Continuous Glucose Monitoring system for use in adults with diabetes, marking the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

  • FMI applauds passage of U.S. House Farm Bill
    The House on Thursday passed legislation to address the economic challenges facing the nation’s farmers and ranchers, while making significant investments in opportunities for Supplemental Nutrition Assistance Program recipients. The move drew praise from the Food Marketing Institute.

  • Supreme Court: States can require e-retailers to collect state sales tax
    The court upheld a 2016 South Dakota law that required e-merchants — even those without physical operations in-state — to collect sales tax “as if the seller had a physical presence in the state,” paving the way for similar legislation in other states.
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