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,...
Read The ArticleWelcome to the first edition of our weekly blog series, “What CITI Program is Reading,” which highlights news articles curated by our staff and relevant...
Read The ArticleOn 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...
Read The ArticleOn 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...
Read The ArticleInvestigators 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...
Read The ArticleThe 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...
Read The ArticleClinical drug and biologics trials should aim to have participants represent the likely users of the approved medication. The FDA has issued guidance for sponsors...
Read The ArticleOHRP 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...
Read The ArticleAs 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...
Read The ArticleOn November 19, 2020 and as part of the of The Hastings Center’s series, Securing Health in a Troubled Time, Dr. Anthony Fauci, Director at...
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