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Licensing

  • GPhA: Including provisions relating to biologics in TPP agreements is 'premature'

    WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

    The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

  • Louisiana seeks to expand pharmacy's ability to immunize patients

    ALEXANDRIA, Va. — The Louisiana State Senate passed legislation that would expand the authority given to pharmacists to administer immunizations.

    State Sen. Fred Mills Jr., R-22, who serves on the Senate Health and Welfare Committee, is the author of SB 60, which would expand pharmacists' authority to provide immunizations to Louisianans ages 18 years and older against pneumonia, shingles, tetanus, diphtheria and pertussis without a prescription.

  • FDA seeks input from stakeholders, public on regulatory approval pathway for follow-on biologics

    SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

    The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.

    In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.

  • PTCB, METC prepare federal pharmacy technicians for success

    WASHINGTON — Pharmacy technicians certified through the Pharmacy Technician Certification Board maximize their training experiences at the Department of Defense Military Education and Training Campus in Fort Sam Houston, Texas, the PTCB said.

    Prior to graduating, students in the METC Pharmacy Technician Training Program are encouraged to take the PTCB’s Pharmacy Technician Certification Exam and gain national recognition as certified pharmacy technicians. Pharmacy techs trained at the METC work in pharmacies operated by the federal government and the military.

  • Mississippi Pharmacy Practice Act signed into law

    ALEXANDRIA, Va. — Mississippi Gov. Haley Barbour recently signed into law the Mississippi Pharmacy Practice Act, which establishes oversight of pharmacy benefit managers (defined as nonresident pharmacies) by the Mississippi Board of Pharmacy.

    The law goes into effect July 1.

  • Most U.S. voters believe an expanded role for nurse practitioners will boost quality of health care

    NEW YORK — Many U.S. voters are in favor of expanding the use of nurse practitioners for routine medical care, and most believe that the quality of health care would improve if routine care was handled by nurse practitioners and doctors were able to focus more on challenging healthcare issues, according to the findings of a recent survey.

    According to a new Rasmussen Reports national telephone survey of 1,000 adults, 67% of likely U.S. voters favored training and licensing nurse practitioners to expand the level of routine care they provide.

  • Forest purchases rights to azimilide

    NEW YORK — Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

    Forest said Tuesday that it had purchased the rights to azimilide from Blue Ash Therapeutics and had been assigned a license agreement between Blue Ash and Warner Chilcott. Forest will assume responsibility for all future development and commercialization, including costs. Financial terms of the deal were not disclosed.

  • PSE's Rx-only switch in Arkansas opens a new can of worms

    WHAT IT MEANS AND WHY IT’S IMPORTANT — The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

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