Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.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 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 approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.
