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FDA clears a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring.[ Price : $8.95]
FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) ...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America suggests things for FDA to consider as it moves forward from a March workshop...[ Price : $8.95]
The Council for Responsible Nutrition asks FDA to reconsider how it uses the drug preclusion clause in the Dietary Supplement Heal...[ Price : $8.95]
FDA approves expanded Magnetic Resonance Imaging labeling for Abbotts Eterna spinal cord stimulation (SCS) system to include new l...[ Price : $8.95]
FDA publishes a Study Data Technical Conformance Guide with specifications, recommendations, and general considerations on how to ...[ Price : $8.95]
Four pharmaceutical stakeholders recommend changes to an FDA question-and-answer draft guidance on electronic systems, records, an...[ Price : $8.95]
FDA orders safety labeling changes for prescription stimulants used to treat attention deficit/hyperactivity disorder and other co...