• Regulatory NewsRegulatory News

    BIO: What it takes to make the leap to decentralized trials

    Though there’s excitement and much promise in leveraging technology to meet participants on home turf, “We’re all still taking baby steps in bringing the clinical trial to the patient,” said Rasika Kalamegham, speaking of making the move to decentralized clinical trials. Moderating a decentralized trial-focused session at BIO Digital, she and other session participants discussed how to tease out where promise lies and what hurdles stand in the way of sponsors, regulators, ...
  • Regulatory NewsRegulatory News

    FDA Says It's Not Interested in Regulating Most Mobile Apps or Wearable Devices

    Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices. The guidance document, General Wellness: Policy for Low Risk Devices , explains that FDA's medical device regulator, the Center for Devices and Radiological Health (CDRH), "does not intent to examine low risk general we...