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FDA publishes a guidance on preparing 510(k) submissions for display devices intended for diagnostic radiology.[ Price : $8.95]
FDA publishes a revised guidance on medical device data systems to conform with the 21st Century Cures Act.[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug applica...[ Price : $8.95]
Federal Register notice: FDA announces a 10/26 public meeting entitled Animal Generic Drug User Fee Act.[ Price : $8.95]
FDA joins with the NIH and other organizations in a new Accelerating Medicines Partnership program on heart failure.[ Price : $8.95]
Sarepta Therapeutics files a BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patient...[ Price : $8.95]
FDA approves Regeneron Pharmaceuticals Dupixent (dupilumab) for treating adult patients with prurigo nodularis. a chronic, inflamm...[ Price : $8.95]
Four stakeholders suggest ways FDA could improve a draft guidance on fit-for-use clinical outcome assessments.