Sponsors, contract research organizations (CROs), and sites should immediately introduce “emergency interim measures” to help sustain clinical trial monitoring as the coronavirus (COVID-19) continues to impact day-to-day life in the […]
A new guidance from the U.S. Food and Drug Administration (FDA) provides direction to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs (INDs) or new […]
Why does it take so long to get new vaccines and medicines to market? It is not a new question, but as governments, communities, and medical professionals around the world […]
The U.S. Food and Drug Administration (FDA) is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. “The FDA’s door is […]
Always the masters of droll understatement, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a directive today (March 12) noting it was “aware that there are challenges […]