LEAD Coalition urges FDA to apply regulatory flexibility in review of aducanumab

On January 20, 142 LEAD Coalition member organizations and allies wrote to urge the FDA to utilize its regulatory flexibility in rendering a decision on biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease. Should FDA approve the application, the letter also recommends […]

LEAD Coalition urges CMS-CDC committee to align ICD-10 coding of mild cognitive impairment with clinical practice

On November 9, 201 LEAD Coalition member organizations and allies wrote to the ICD-10 Coordination and Maintenance Committee (C&M) — a federal interdepartmental committee comprised of representatives from the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) — to urge that it adopt […]