FDA approves a PMA for the Recor Medical Paradise renal denervation system to treat hypertension.
Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible syringes labeling c...
A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manifestations of junctio...
Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Lis...
Former FDA reviewer Sarah McGarry joins consulting firm Greenleaf Health as senior vice president of drug and biological products.
The CDER Office of Prescription Drug Promotion says two Otsuka Rexulti ads contain misleading presentations of the drugs efficacy.
FDA warns Irvine, CA-based Neurotris about multiple violations in its illegal manufacturing and distribution of muscle stimulator devices known as the...
FDA publishes a guidance with recommendations for select NDAs and BLAs submitted for Real-Time Oncology Review.
