Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).
FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research Center of Atlanta.
FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from donor adipose tissue ...
PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.
Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using a biologic with a d...
Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.
CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patients.
Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
