FDA

Drug pricing and opioids have remained front and center as the 116th Congress got sworn in and started hosting hearings and…

Scott Gottlieb, MD, Commissioner of the United States Food and Drug Administration (FDA), announced his resignation from his post…

The Office of the National Coordinator for Health IT (ONC) has come under fire for what some consider a slow implementation of the…

Smartphones have become ubiquitous today. Need a cab? There’s an app (or several) for that. Need to order groceries to be…

On January 24, 2019, the United States Food and Drug Administration (FDA) released two draft guidances focused on improving the…

Recently, the U.S. Food and Drug Administration’s (FDA) director of the Center for Drug Evaluation and Research (CDER) described…

For over two decades, 1996 has stood out as a successful year for drug approvals, with a whopping 53 approvals following a new…

On January 7, 2019, the Supreme Court of the United States (SCOTUS) heard oral arguments about who has the final say in warnings…

In September 2018, the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)…

The US Food and Drug Administration (FDA) recently proposed changes that would allow institutional review boards (IRBs) to waive…