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Regulatory and Washington

  • FDA setting stage for NDUFA with June public meeting

    SILVER SPRING, Md. - OTC suppliers may soon have a streamlined highway to the kind of sales-driving product innovation that Rx-to-OTC switch generates using monographs, according to an announcement from the Food and Drug Administration issued Tuesday. However, it may be a toll road.
     

  • Inc.: Small company takes on FDA - and wins

  • CRN objects to proposed 3rd-party verification rule for military retail outlets

    WASHINGTON — The Council for Responisble Nutrition on Wednesday stood up against a proposed pre-market approval requirement on dietary supplements being sold on U.S. military bases. 
     

  • CDC: At least 30% of antibiotic scripts unnecessary

    ATLANTA — The Centers for Disease Control and Prevention, according to new data published Tuesday in the Journal of the American Medical Association that at least 1-in-3 antibiotic prescriptions are unnecessary. The study looks at antibiotic use in doctors’ offices and emergency rooms nationwide, finding that some 47 million excess antibiotic prescriptions are written for viral respiratory conditions. 
     

  • NCPA to host 2016 Congressional Pharmacy Summit May 24-25

    ALEXANDRIA, Va. - The National Community Pharmacists Association on Monday announced it will hold its 2016 Congressional Pharmacy Summit May 24-25, when hundreds of community pharmacists will visit the nation's capital to advocate for community pharmacy and their patients.
     

  • Allergan to offer Liletta IUD at discount to VA

    DUBLIN — Allergan on Monday announced the launch of its “Liletta Access on the Front Line” initiative, which is aimed at allowing active duty and retired military members better access to long-acting reversible contraception. 
     

  • Georgia becomes state No. 33 to adopt NPLEx

    WASHINGTON - Georgia earlier this week became state No. 33 to adopt the real-time, stop-sale technology called the National Precursor Log Exchange, a blocking system used across the country which prevents the illegal sale of pseudoephedrine, an ingredient sometimes used in the production of methamphetamine. 
     

  • Access to care provision part of CMS’ Medicaid managed care final rule

    ARLINGTON, Va. – The National Association of Chain Drug Stores on Wednesday praised the Center for Medicare & Medicaid’s inclusion of network adequacy standards — which would improve patient access to care in Medicaid and the Children’s Health Insurance Program — in the Medicaid and CHIP Managed Care final rule the agency released on April 21.
     
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