CDER director Patrizia Cavazzoni says ORP director Elizabeth Jungman will become FDA commissioner Robert Califfs chief of staff.
FDA cautions that there is the potential for elevated levels of formaldehyde being released when two GE HealthCare compressors are used with specified...
FDA warns Czechias Deymed Diagnostic about QS violations in its production of non-sterile Class 2 medical devices.
FDA warns Ponce, Puerto Rico-based Prime Labs about significant CGMP regulation violations in its production of finished drugs.
Leiters Health recalls 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency.
Federal Register notice: FDA issues a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining approval of Casgevy (e...
FDA approves Bausch + Lombs Teneo Excimer Laser Platform for LASIK vision correction surgery for myopia and myopic astigmatism.
FDA approves a Medtronic PMA for its Percept RC Deep Brain Stimulation system.
