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 guidance on procedures for submitting section 513(g) requests for information on medical device classification.
Liquidia Corp. sues FDA over the agencys recent decision to grant United Therapeutics Corp. an additional three-year exclusivity period for Tyvaso DPI...
FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.
PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.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...
