The U.S. Food and Drug Administration (FDA) has issued a guidance authorizing the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices […]
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 […]
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 […]
Today (March 20), the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their use so […]
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) today (March 19) published a guidance on "Managing clinical trials during Coronavirus (COVID-19)" to advise those involved […]