The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has changed some of its day-to-day operational procedures and extended some marketing deadlines in response to […]
Clinical research study sites are rapidly becoming more concerned about coronavirus-related interruptions to clinical trial recruitment and retention, with domestic site concern levels jumping from 25% to 47% as of […]
The U.S. Food and Drug Administration (FDA) will hold a virtual town hall tomorrow (March 25) at 3 p.m. Eastern Time designed for clinical laboratories and commercial manufacturers that are […]
Ed Seguine is a big believer in the power of technology to advance clinical trial quality, efficacy, and efficiency. So, why is he concerned by certain vendors’ promises made in […]
The European Commission, the European Medicines Agency, and the Heads of Medicines Agency have published a new guidance for study sponsors on how to manage the conduct of clinical trials […]