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  • Regulatory NewsRegulatory News

    Canadian Thalidomide Survivors Still Awaiting Details on Compensation Package

    Canadian thalidomide survivors are still waiting for details on a support package intended to compensate survivors and assist with their medical needs. "We began our campaign twelve months ago with ninety-seven survivors. Today, ninety-four remain," said Mercédes Benegbi, thalidomide survivor and executive director of the Thalidomide Victims Association of Canada (TVAC), in a press release yesterday. On 6 March 2015, the Canadian government announced it would prov...
  • Regulatory NewsRegulatory News

    UK Regulators Prepare for Review of 'Forgotten Thalidomide'

    Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages. The information will be used as part of an independent review to determine whether there is a causal relationship between HPT use and reported side effects. MHRA is asking for submissions by 30 June 2015, and says the repo...
  • Regulatory NewsRegulatory News

    Health Canada Clarifies Compensation Package for Thalidomide Victims

    For the second time in history, the Canadian government will provide compensation to victims of the infamous drug Thalidomide. Background Thalidomide was originally marketed in several countries as a morning sickness drug by Chemie Grünenthal in the late 1950s and early 1960s until its use was linked to thousands of deaths and birth defects. Approximately half of the surviving infants who were exposed to Thalidomide in the womb suffer from malformed limbs. The drug al...
  • 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...
  • FDA Releases Draft Guidance for Lenalidomide Bioequivalence Testing

    • 05 November 2012
    The US Food and Drug Administration (FDA) has released a new draft guidance regarding bioequivalence (BE) recommendations for lenalidomide capsules. Lenalidomide capsules, marketed by Celgene Corporation under the trade name Revlimid , are an analogue of Thalidomide and used to treat multiple myeloma. The latter was notorious in the late 1950s and early '60s for causing horrific birth defects in countries where the drug was approved-which did not, as FDA is proud to n...
  • After 50 Years, Victims Finally Receive Apology from Thalidomide Manufacturer

    • 04 September 2012
    More than half a century after German drug manufacturer Grünenthal Group set into motion a new era of global drug regulation after its morning sickness drug Thalidomide was linked to deaths and serious birth defects, the company has offered something long sought by activists: an apology. Speaking at an unveiling of a Thalidomide Memorial in Rhineland, Germany, Grünenthal CEO Harald Stock offered his "sincere regrets" and "deep sympathy for all those affec...
  • Hamburg: Smart Regulation Supports Public Health and Innovation, FDA Creating Business Liaison

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg delivered a speech at the Commonwealth Club of San Francisco on 6 February in which she discussed FDA's dual role in protecting health and getting innovative products to market. "As FDA commissioner, I have been surprised by how many people ask whether I favor safety or innovation," said Hamburg. "I favor both." "Protecting the public health-while encouraging, not discouraging innovation must be the ...