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Regulatory and Washington

  • FDA fortifies VMS oversight with revised draft guidance on NDIs

    SILVER SPRING, Md. - In the latest move to fortify regulations governing the dietary supplement industry, the U.S. Food and Drug Administration on Thursday issued a revised draft guidance to improve dietary supplement companies' new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

    In response to the news, the Council for Responsible Nutrition joined Informa Exhibitions with plans for an industry-wide webinar on the topic of New Dietary Ingredient Notifications.

  • Authorized Generics: Q&A with Greenstone's Jim Cannon

    Jim Cannon, Greenstone VP and general manager

  • Latest CDC study proves boomers benefit from flu shot

    ATLANTA - A new CDC study published Tuesday in the journal Clinical Infectious Diseases provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had gotten a flu vaccine reduced their risk of flu-associated hospitalization by half.

  • Big-money meds lose patent protection in 2016

    Total spending on products whose patents expired between 2012 and 2015 declined by $14.2 billion last year, according to IMS Health’s Institute for Health Care informatics. And 2016 could bring about further cost reductions.

  • CDC, Brazil Health Ministry including FC2 in Zika prevention kits

    ATLANTA - The Zika virus has hit the coast of Florida in the Miami area, specifically the Wynwood neighborhood, the Centers for Disease Control and Prevention reported Monday.

    Based on the confirmation of local Zika transmission in Florida, CDC has updated its Interim Zika Response Plan and has released the Zika Community Action Response Toolkit to help states with risk communication and community engagement when local transmission is identified.

  • Companies fight to launch biosimilars amid expiries

    In April, the Food and Drug Administration granted approval to Pfizer’s Inflectra (infliximab) — a biosimilar of Janssen’s Remicade and possibly the second biosimilar to be launched in the United States. But like the first biosimilar, Zarxio (filgrastim-sndz), Inflectra is subject to a 180-day waiting period before launch, and is currently facing opposition from Janssen, which claims Remicade’s patent doesn’t expire until 2018.

  • House Speaker Paul Ryan recognizes Walgreens safe medication milestone

    DEERFIELD, Ill. - In the first national effort of its kind by a retailer, Walgreens has installed safe medication disposal kiosks at 288 pharmacies across 21 states and Washington D.C. Walgreens is now more than halfway toward its goal, announced in February, of installing medication disposal kiosks at 500 locations around the country, the company announced Monday.

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