FDA classifies as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors.
The Justice Department files two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid k...
FDA posts a draft guidance on Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.
Federal Register notice: FDA finalizes a ban on electrical stimulation devices for self-injurious or aggressive behavior.
U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduce the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intend...
Hikma Pharmaceuticals extends a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials due to...
FDA warns Reproductive Technologies about significant deviations from regulations for human cells, tissues, and cellular and tissue-based products.
Federal Register notice: FDA withdraws its 2006 guidance entitled Exocrine Pancreatic Insufficiency Drug Products Submitting NDAs.