FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters As we have with...

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying...

The U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12...

The U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older...

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech...

Updated: 4/15/2024 Introduction Provision Consulting Group ("PCG") ensures compliance with the US Food and Drug Administration ("FDA")...

Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? Those are...

How to Study and Market Your Device Medical devices marketed in the United States are subject to the regulatory controls in the Federal...

The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of...

The U.S. Food and Drug Administration(FDA) announced the following actions taken in its ongoing response effort to the COVID-19 pandemic...