Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.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FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.
PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regneron BLA for a multi...
