Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Similar Posts
Healwell Homeo Private Limited – 706206 – 06/12/2025
CGMP/Finished Pharmaceuticals/AdulteratedMedisourceRx – 717970 – 12/12/2025
Compounding Pharmacy/Adulterated Drug ProductsModel Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions – 03/13/2025
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory SubmissionsGlucose Monitor Sensor Recall: Abott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readingsHorizon Tool Inc. – 706567 – 06/06/2025
CGMP/Finished Pharmaceuticals/AdulteratedMade Fresh Salads, Inc. Recalls Assorted Flavors of Cream Cheese Because of Possible Health Risk
Made Fresh Salads, Inc. of Bay Shore, NY is recalling assorted flavors of cream cheese because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weaken