• Regulatory NewsRegulatory News

    BIO Highlights IP Challenges Around the Globe

    As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products. "These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentabil...
  • Regulatory NewsRegulatory News

    Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System

    A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected with the disease. In...
  • GSK Bets Big on Bioelectronic Medicine as Regulatory Questions Loom on Horizon

    • 08 August 2013
    Back in April 2013, Focus covered a rather futuristic-sounding announcement from GlaxoSmithKline regarding its funding of a new field of medicine the company was calling "electroceuticals"-more formally known as bioelectronic medicine-an emerging field of medicine that might one day use the body's own electronic signals to treat patients. While the initial funding was small-just $1 million, a miniscule fraction of GSK's $40 billion in annual revenue last year-the compan...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...
  • RAPS' LatestRAPS' Latest

    Choosing the Right Regulatory Career: An Inside Look

    "Choosing the Right Regulatory Career" looks at the wide range of opportunities available to those interested in the regulatory profession. The 21 authors, all experienced regulatory professionals, discuss the role of the regulatory professional in a variety of settings including large and small prescription drug companies, generic pharmaceutical companies, medical device and IVD manufacturers, Institutional Review Boards and consultancies, as well as specialties suc...