FDA publishes an online page describing hernias and their repair, with attention to using surgical mesh in the repair.
Draeger Medical recalls its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of...
FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.
FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from prescription to over...
FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.
CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim uses an agency podcast to urge companies to conside...
FDA warns Santa Rosa, CA-based NeilMed Pharmaceuticals about CGMP and other issues in its production of finished drugs.
VeganMed asks FDA to require drug and dietary supplement manufacturers to disclose in product labeling any animal-derived ingredients in their product...
