Retest for COVID-19
People who’ve had COVID-19 should be swab tested again 4 or more weeks after symptoms first appear to minimise the risk of onward infection, suggests a large population based study in one of Italy’s former coronavirus hotspots, and published in the online journal BMJ Open. This is because SARS-CoV-2, the virus responsible for COVID-19 infection, takes an average of 30 days to clear from the body after the first positive test result and an average of 36 days after symptoms first appear, the study findings show. And it’s not yet known how infectious a person may be in the recovery phase, warn the researchers.
FDA responds to COVID-19: Regulatory innovation in the face of a pandemic
To meet the challenges of the COVID-19 pandemic, the all-hazards preparedness framework of the U.S. Food and Drug Administration (FDA) equips the agency with specific authorities for use during emergency situations. Actions to date range from efforts to expedite access to timely medical products to initiatives to protect consumers from health fraud. More details at HealthAffairs.org
Pilot program to communicate patient reported outcomes from cancer clinical trials
The U.S. Food and Drug Administration (FDA) has launched Project Patient Voice. Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. “The Project Patient Voice pilot is a significant step in advancing a patient-centered approach to oncology drug development,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Where patient-reported symptom information is collected rigorously, this information should be readily available to patients.”