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7 catalysts · 9,757 approval · 5,000 device 510k · 4,728 grant · 2,730 8k filing · 2,000 device pma · 2,000 device recall
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7 catalysts · 9,757 approval · 5,000 device 510k · 4,728 grant · 2,730 8k filing · 2,000 device pma · 2,000 device recall
Therapy area: Dermatology. Indication: Chronic Urticaria
Therapy area: Infectious Disease. Indication: Human Immunodeficiency Virus (HIV) Infections (AIDS)
Therapy area: Metabolic Disorders. Indication: Type 1 Diabetes (Juvenile Diabetes)
Therapy area: Central Nervous System. Indication: Dementia Associated With Alzheimer's Disease
Prescription Drug User Fee Act goal date of July 17, 2026
action date of January 4, 2027
action date of Jan. 21, 2027