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Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.[ Price : $8.95]
FDA approves and issues an emergency use authorization for Moderna and Pfizer Covid-19 updated mRNA vaccines targeting the most pr...[ Price : $8.95]
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 s...[ Price : $8.95]
FDA gives Wex Pharmaceuticals a fast-track designation for Halneuron (tetrodotoxin for injection), an alternative to narcotics and...[ Price : $8.95]
FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.[ Price : $8.95]
FDA publishes a guidance on procedures for submitting section 513(g) requests for information on medical device classification.[ Price : $8.95]
Liquidia Corp. sues FDA over the agencys recent decision to grant United Therapeutics Corp. an additional three-year exclusivity p...[ Price : $8.95]
FDA approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.