Operation Warp Speed Had Trouble Enrolling Patients In COVID-19 Therapeutic Research
US FDA Acting Commissioner Woodcock says there is ‘a long list’ of lessons learned in the OWS therapeutics group, noting trial bureaucracy and the lack of resources and support for community centers.
You may also be interested in...
COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies
‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.
Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.
False Claims Act Liability: Defendant’s Belief Claims Were False Matters, Supreme Court Finds
In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.