• Eleven Pieces of Supporting Evidence Likely to Earn Your Company an Untitled Letter from FDA

    Not all evidence is created equal, and understanding what claims can be made based on what evidence is important to remaining in compliance with US federal law and avoiding Untitled or Warning Letters from the US Food and Drug Administration (FDA). That's the advice given by Julie Tibbets, a partner at Alaston & Bird LLP, at a recent conference hosted by the Food, Drug and Law Institute (FDLI) in Washington, DC. While noting the general "downward trend in letters" ...
  • Europe-wide HTA Database Opened for HTA Agencies

    • 09 November 2012
    A new first-of-its-kind database, the European Evidence Database on New Technologies ( EVIDENT ), is now accessible for all government-appointed Health Technology Assessment (HTA) agencies in Europe, related regional agencies and not-for-profit organizations. The database permits HTA agencies to register Additional Data Collection (ADC) studies they have undertaken to fill gaps in HTA-related information as well as search for studies being registered by other HTA agencie...
  • Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

    Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track . That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, ...