FDA

In a recent presentation at the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, Catherine Gray, the…

On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright…

Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…

Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…

Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…

Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…

The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…

The Food and Drug Administration (FDA) released two new guidances for drug and device companies looking to communicate…

The Food and Drug Administration (FDA) recently announced an opportunity for public comment on the statement of work for an…

The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to…