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Regulatory and Washington

  • APhA students make trip to DC to advocate for pharmacy

    WASHINGTON - The American Pharmacists Association Academy of Student Pharmacists, with the support of Amgen, Cardinal Health and Rite Aid, held leadership and professional development programming this weekend in Washington for 240 student pharmacists. The schedule kicked off with 223 student pharmacists visiting 125 Congressional offices on Capitol Hill to advocate for pharmacists' recognition as 'providers' in health care.

  • Industry orgs respond to PDUFA reauthorization letter

    SILVER SPRING, Md. and WASHINGTON — The Food and Drug Administration on Friday released a document containing details — procedures and performance goals — for the Prescription Drug User Fee Act (PDUFA) reauthorization, or PDUFA VI. 
     

  • PhRMA names Stansel EVP, general counsel

    WASHINGTON —  The Pharmaceutical Research and Manufacturers of America on Tuesday announced that James Stansel would be joining the organization as EVP and general counsel, effective Aug. 1. Stansel will oversee the organization’s legal department. 
     

  • FDA makes big progress on GDUFA backlog

    SILVER SPRING, Md. — The Food and Drug Administration’s Center for Drug Evaluation and Research has achieved its goal of clearing some of the backlog under the Generic Drug User Fee Agreement, according to an email sent by CDER director Janet Woodcock. 
     

  • CHPA, FDA discussing user fee program for OTC drugs

    WASHINGTON —  Since the Food and Drug Administration’s March 25, 2014 Part 15 public hearing on the OTC Drug Monograph, the Consumer Healthcare Products Association has been in discussions with FDA and relevant committees in Congress to identify potential enhancements that would update and modernize this regulatory framework for most nonprescription medicines.

  • APhA warns new language and anti-discriminatory rules may impact pharmacy

    WASHINGTON - Beginning July 18, pharmacies will be required to abide by rules that regulate discriminatory behavior and practices, such as refusing to provide adequate language assistance services to customers with limited English proficiency or refusing to dispense medications for gender transitions.

  • Walgreens to spearhead enrollment for PMI Cohort Program

    DEERFIELD, Ill. - Walgreens will participate in the U.S. Precision Medicine Initiative Cohort Program through an initial $20 million grant awarded to The Scripps Research Institute by the National Institutes of Health, the retail pharmacy operation announced Thursday. The company will help support patient enrollment and participation in the program through its daily interactions with more than 8 million customers in stores, online and through its mobile app.

  • CRN establishes VMS product registry

    WASHINGTON — The Council for Responsible Nutrition on Tuesday announced it has retained UL, a global independent safety science company, to develop and administer the dietary supplement product registry that CRN says “will help create a fuller picture about the dietary supplement industry for industry regulators and serve retailers as a one-stop shop to help compare product labels.”

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