NEWS

FDA proposes new rule on reporting requirements to support Right to Try On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an annual summary of such use to FDA. The Right to Try Act (RTT), or the Trickett Wendler, Frank Mongiello,

EU cancer estimates for 2020 reveal 2.7 million new cases

American Association for Cancer Research Forum addresses racism and inequality in cancer trials

European medicines agencies launch public consultation on joint strategy The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years. It was recently released for a two-month public consultation period (6 July, 2020). It outlines six priority areas: the availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance and

Two new reports find impacts of COVID-19 on clinical trials easing slightly According to findings released by GlobalData Healthcare (9 July, 2020) disruption caused to clinical trials by the COVID-19 pandemic is beginning to ease slightly. After three months of increasing disruptions to trials largely attributed to suspended enrolment there is some evidence of green shoots.  Trials that were disrupted due to suspended enrolment are showing signs of recovery

Risk Based Monitoring- a data-centric approach to monitoring