FDA publishes a guidance to help submitters of de novo requests use an electronic format template.
FDA clears Procept BioRobotics Hydros Robotic System used for aquablation therapy in patients with benign prostatic hyperplasia.
FDA principal deputy commissioner Namandj Bumpus says CDER correctly denied approval of a 2016 Intarcia NDA for ITCA 650 to treat Type 2 diabetes.
Federal Register notice: FDA announces a 9/26 Oncologic Drugs Advisory Committee meeting to discuss the use of immune checkpoint inhibitors in patient...
Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.
FDA approves and issues an emergency use authorization for Moderna and Pfizer Covid-19 updated mRNA vaccines targeting the most prevalent variant.
Defibtech begins a Class 1 recall of its RMU-2000 ARM XR Chest Compression Devices due to a motor problem that may cause them to stop compressions.
FDA gives Wex Pharmaceuticals a fast-track designation for Halneuron (tetrodotoxin for injection), an alternative to narcotics and opioids for treatin...
