The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according…
International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic. Building a strong infrastructure to monitor vaccine safety and effectiveness, putting together international clinical cohorts of patients with COVID-19 infection and pregnancy research were identified as priority areas for cooperation during a workshop held 19 May 2020 under…
FDA this week announced a project with health tech company Aetion to track and analyze Covid-19 treatments and diagnostics in a bid to better understand what works — and what doesn’t. The new partnership with Aetion — where former Commissioner Scott Gottlieb sits on the board — is part of an “all hands on…
The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19, including how diagnostics and medications are being used in the pandemic and how best…
The US Food and Drug Administration (FDA) on Tuesday said it will partner with New York-based health technology firm Aetion, Inc. to develop real-world data analytics to answer pressing questions related to coronavirus disease (COVID-19). “Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms,…
The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are effective. The Food and Drug Administration is already using its internal drug monitoring system called Sentinel to learn more…
Michelle McMurry-Heath doesn’t talk about biotech the way her peers do. Where other executives and experts might bring up “access,” and “reimbursement,” McMurry-Heath talks about fairness and ethics. “Science is the social justice issue of our age,” McMurry-Heath said. “Making sure that knowledge gets out to the people who need it, that, to…
Responding to COVID-19 is forcing regulators, medical product developers and health systems to get real about real-world data and evidence as they reach for every available tool to learn about the disease and speed the development of effective interventions. Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the…
Senators Edward J. Markey (D-MA) and Thom Tillis (R-NC) and 31 of their Senate colleagues are calling for protections for the U.S. scientific research community during the coronavirus pandemic. Although novel coronavirus-related research is a current federal government priority, most other research has slowed or stopped due to closures of campuses and laboratories. The…
Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated its ability to kill people of all ages. Even as the country edges back to…
