By Kevin Truong, MedCity News | April 24, 2019 At the MedCity INVEST Conference in Chicago, the FDA's Bakul Patel spoke about the recent developments in the agency's thinking about regulating the emerging Software as a Medical Device space. The emergence of new data sources and the ubiquity of cloud [...]
By Conor Hale, FierceBiotech | April 3, 2019 The FDA has begun to reconsider how it reviews and approves medical devices that employ artificial intelligence and to learn from data to adapt their care. The agency hopes a tailored regulatory framework will help promote the development of machine-learning devices and [...]
By Laura Lovett, MobiHealth News | March 28, 2019 A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools. Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. [...]
By Alaric Dearment, MedCity News | March 15, 2019 The guidance concerned strategies for developing precision medicines and more efficient clinical trial oversight. But the outgoing commissioner criticized drugmakers and CROs' reluctance to change their ways. Following a raft of new proposals designed to expand eligibility for cancer clinical trials, [...]
By Mike Miliard, Healthcare IT News | March 05, 2019 At the Food and Drug Administration, the physician and venture investor promoted policies focused on innovating approaches to population health, opioids, chronic disease, AI and precision medicine. Food and Drug Commissioner Dr. Scott Gottlieb announced his resignation from the FDA [...]
By Dave Muoio, MobiHealth News | February 6, 2019 Released yesterday, the document outlines FDA's preference toward single applications for combination products. The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories. [...]
