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CDER director Patrizia Cavazzoni says agency inspectors and reviewers are seeing deteriorating manufacturing quality in the facili...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device De Novo R...[ Price : $8.95]
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recomm...[ Price : $8.95]
FDA clears a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit.[ Price : $8.95]
Inari Medical begins a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adv...[ Price : $8.95]
FDA publishes a guidance to help submitters of de novo requests use an electronic format template.[ Price : $8.95]
FDA clears Procept BioRobotics Hydros Robotic System used for aquablation therapy in patients with benign prostatic hyperplasia.[ Price : $8.95]
FDA principal deputy commissioner Namandj Bumpus says CDER correctly denied approval of a 2016 Intarcia NDA for ITCA 650 to treat ...