Unapproved New Drugs/Misbranded
Similar Posts
FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.Blue Bell Ice Cream Issues Allergy Alert on Undeclared Almond, Walnut, and Pecan in Moo-llennium Crunch Ice Cream Packaged in a Chocolate Chip Cookie Dough Half Gallon Carton with a Moo-llennium Crunch Ice Cream Lid
BRENHAM, Texas, August 22, 2025 – Blue Bell Ice Cream is voluntarily recalling a limited quantity of Moo-llennium Crunch Ice Cream half gallon packaged in a Chocolate Chip Cookie Dough carton produced in its Brenham, Texas, plant because of undeclared almond, walnut, and pecan. The recalled productWhy Protecting Confidential Information is Key to the FDA’s “Gold Standard”
The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates as well as personal data.Pediatric Tracking Requirements Under FDAAA
Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAAFDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity
The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system