On Tuesday, the agency sent warning letters to 10 pharmaceutical companies threatening legal action for improperly listed patents, and notified the FDA that it disputes the accuracy or relevance of ...

U.S. District Judge Zahid Quraishi’s granting of summary judgment against the two drug behemoths squashes their arguments.

From 2020-2021, more than 10 percent of globally manufactured active pharmaceutical ingredients (API) — 147 compounds — were linked to drug shortages in the US, according to a research letter ...

In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final ...

Sen. Bernie Sanders (I-Vt.), chair of the Committee on Health, Education, Labor and Pensions (HELP), has informed Novo Nordisk CEO Lars Fruergaard Jorgensen in a scathing letter that charging ...

Cardinal did not notify the FDA that it planned to introduce the devices into commercial distribution causing them to be misbranded.

Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases to apply for accelerated approval (AA) to give the promising space a leg up in development.

A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version 5.8.0 ...

Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in the FDA’s Form 483 ...

CDRH has hired an architecture firm specialized in designing “innovative buildings with health and equity in mind.” ...

The website has a simple text box for consumers to describe their complaint, which will undergo preliminary review by FTC.