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Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.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...
FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.
FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.
