Readers had a lot to say about my latest column on the Food and Drug Administration’s proposed front-of-package labels. Most ...
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
The Food and Drug Administration is using its most severe notice in a recall of more than 6,000 bags of chips in two states ...
America First Legal sent letters to dozens of officials across the country, warning of possible incarceration or a civil RICO case if they follow their local policies meant to protect immigrants.
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
Barclays has sounded the alarm over a letter going out to customers, after a complaint from an individual regarding a change to their account. The customer reached out to the bank on social media ...
Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...
The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did ...
A structured interview was developed to assess correct interpretation of eight common medication warning labels developed by Pharmex, the largest U.S. pharmacy supplier of adhesive warning labels.
After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ ...