• Fund to Provide for England's Thalidomide Victims

    • 21 December 2012
    This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50 th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act), a piece of legislation aimed at improving regulatory oversight over healthcare products. Worldwide, regulators marked a more ominous anniversary: 50 years since the drug Thalidomide was introduced to the world . The introduction of t...
  • UK: First Oral Therapy for MS Gets NICE Approval

    In final guidance released 24 April, the UK's National Institute for Clinical Exellence (NICE) recommends that the National Health Service provide Novartis' fingolimod (Gilenya) as long as it gets a special NHS discount from the manufacturer.  Fingolimod is the first pill-based medicine to help reduce the number of relapses for some adults who have highly active relapsing-remitting multiple sclerosis (RRMS) - only if Novartis provides the drug at a confidenti...
  • MHRA Asking for Feedback on Updating, Removing Regulations

    The Medicines and Healthcare products Regulatory Agency (MHRA) is petitioning the public for feedback on its regulations, including which to improve and which to remove altogether. The move is part of the UK government's "Red Tape Challenge", which seeks to "cut unnecessary and over burdensome regulations." "[T]he Red Tape Challenge asks whether existing regulations are really providing the protection that is intended, or are they unnecessary or overcomplicated and need...