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Regulatory and Washington

  • Increased patient control could put health reform back on track

    As critics of the Affordable Care Act continue to grumble about how the law has adversely affected much of the nation’s healthcare system, consultant and Foundation for Health Smart Consumers fellow Mike Tarino said that giving people more control over how their healthcare dollars are spent could help quiet the critics and put what many see as a failing reform plan back on track.

  • DEA places kratom plant onto schedule I

    WASHINGTON - The Drug Enforcement Administration last week announced its intention to place the active materials in the kratom plant into Schedule I of the Controlled Substances Act in order to avoid an imminent hazard to public safety.

  • FDA approves expanded indication for Amgen's Blincyto

    SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s supplemental Biologics License Application for an expanded indication for its Blincyto, the company said Thursday. 
     
    The drug is now approved for treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The indication was granted under accelerated approval. 
     

  • FDA reaches agreement with generics industry on new GDUFA commitments

    WASHINGTON — The Food and Drug Administration and the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient manufacturers and contract manufacturing organizations — have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.

  • FDA warns against combined use of opioids and benzodiazepines

    SILVER SPRING, Md. - The U.S. Food and Drug Administration announced Wednesday that it is requiring class-wide changes to drug labeling, including patient information, for almost 400 products to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system depressant drugs called benzodiazepines.

  • Washington insider Charlie Cook to address CRN annual meeting

    WASHINGTON — The Council for Responsible Nutrition on Monday announced that the ultimate Washington insider, Charlie Cook, editor and publisher of the Cook Political Report and columnist for the National Journal, will share his political perspectives with attendees of The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry in October.

  • Report: Biosmilar regulatory pathway promising but there are sill barriers

  • Report: FTC taking closer look at M&As concerning generic pharmaceuticals

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