Cordant Health Solutions, which provides healthcare testing and monitoring nationwide, have agreed to pay $845,108 to federal and state governments as part of a civil…
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,…
A recent observational study by the Icahn School of Medicine at Mount Sinai has shown that physiological data from a wearable device can predict COVID-19…
Introduction Clinical research has taught us vital public health lessons over the years. We now know that smoking is a significant risk factor for emphysema,…
Welcome to the first edition of our weekly blog series, “What CITI Program is Reading,” which highlights news articles curated by our staff and relevant…
On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as…
On 22 December 2020 the U.S. Centers for Disease Control and Prevention (CDC) updated their Ensuring the Safety of COVID-19 Vaccines in the United States…
Investigators can request discretionary Certificates of Confidentiality (CoCs) from the U.S. Food and Drug Administration (FDA) for non-federally funded research that is subject to FDA…
The Department of State’s Exchange Visitor Program (BridgeUSA) has issued Guidance Directive Exchange Visitor Program – Confucius Institutes 2020-01, which provides new guidance on the relationship…
Clinical drug and biologics trials should aim to have participants represent the likely users of the approved medication. The FDA has issued guidance for sponsors…
OHRP has added an annotated comparison of the pre-2018 Common Rule with the 2018 regulations. On this page you’ll also find additional information about whether…
As we continue to work together to fight COVID-19, we are reminded of the importance of volunteers to serve in vaccine trials. But deciding to…
