• Regulatory NewsRegulatory News

    Researchers Call for Transparency When Black Box Warnings Are Removed

    A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels. In a recent article appearing in Drug Safety , James Yeh, Ameet Sarpatwari and Aaron Kesselheim of Bringham and Women's Hospital and Harvard Medical School argue that by making the process to remove such warnings from drugs "uniform and transparent," FDA could increase public...
  • In Shift, GSK to Publish Clinical Trials Data

    • 11 October 2012
    Under fire from industry critics, UK drug manufacturing giant GlakoSmithKline has announced its intent to publish clinical trials data-a first for both the company and the pharmaceutical industry, which has historically guarded such data closely to limit potential risk. In a statement, the company said it intends to share, "Detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patient...