RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

    More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost. The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmar...
  • Regulatory NewsRegulatory News

    EMA Defends Changes to Trials Transparency Plan as Advocates go on Attack

    The European Medicines Agency (EMA) is defending its updated clinical trials transparency policy, now derided by some as ineffectual and contrary to its original aims, as being a "compromise approach" meant to placate concerns within industry that too much transparency would have had detrimental effects. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies we...