Blog

Alleged False Claims Acts Violations Prove Costly for Healthcare Company and Lab

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...

Read The Article

What CITI Program is Reading – 2/16/21

“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,...

Read The Article

Wearable Device Data Identifies COVID-19 Infection and Predicts Diagnosis

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...

Read The Article

Practical, Efficient, and Cost-Effective Study Designs in Observational Research

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 Article

What CITI Program is Reading – 2/9/21

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...

Read The Article

FDA’s New AI/ML Device Regulation Action Plan

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...

Read The Article

CDC and Vaccine Safety

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...

Read The Article

New FDA Guidance on Certificates of Confidentiality

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...

Read The Article

New Guidance on College and University J-1 Exchange Programs

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...

Read The Article

FDA Guidance for More Inclusive Clinical Trial Enrollment Practices

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...

Read The Article