The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...

The U.S. Food and Drug Agency is not really a singular agency. In practice, it operates more like five or more “FDAs” — each covering drugs, devices ... FDA’s drug approval authority ...

The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.

With the number of bogus remedies and treatments floating around, claiming to provide relief for various ailments, the FDA really ... Of course, scoring approval for the devices to be used on ...

Patented genetics from Charlotte’s Web were used in the process. There are very rare instances when cannabis-based drug candidates have achieved FDA approval, with only one containing cannabis ...

Humacyte, Inc. has announced that the FDA has granted full approval for SYMVESS, a novel bioengineered human tissue designed for use as a vascular conduit in patients with extremity arterial ...